Product Specialist – Implements

Advanced Quality, Senior Engineer

Legal Analyst (Bilingual) Arabic & English

Staff Engineer – Chemical & Slurry Systems (Global Facilities Engineering)

Forward Deployed AI Strategist

Sr. Manager, Quality & Reliability Engineering

R&D/Product Dvl Engineer II

Principal/Staff, Firmware and Product Test (SSD)

Process Engineering Manager

Site Quality Leader

Responsibilities: Product Planning &amp; Category Management <ul><li>Conduct category research, competitive analysis, and product benchmarking to identify market opportunities and trends.</li><li>Support product roadmap development using market insights and field feedback.</li><li>Define product requirements and specifications aligned with customer applications and regional needs.</li></ul> Technical Evaluation &amp; Product Development Support <ul><li>Evaluate product specifications to ensure performance, reliability, and cost competitiveness.</li><li>Support sourcing, capability assessment, and technical alignment of vendors.</li><li>Lead sample evaluation, field testing, and validation for product selection.</li><li>Provide technical recommendations to cross-functional teams.</li><li>Technical Documentation &amp; Knowledge Management</li><li>Develop and maintain product specs, application guides, and technical documentation.</li><li>Create training materials for internal teams and dealers.</li><li>Ensure accurate and up-to-date product information across systems.</li></ul> Technical Support &amp; Field Enablement <ul><li>Act as the escalation point for complex product issues and provide troubleshooting support.</li><li>Conduct field validations, demonstrations, and performance assessments.</li><li>Collaborate with Service and Quality teams to resolve issues and improve products.</li></ul> Requirements: Education <ul><li>Bachelors degree in Mechanical Engineering, Agricultural Engineering, or a related technical discipline.</li><li>An equivalent combination of technical education and hands-on agricultural/off-highway equipment experience may be considered.</li></ul> Requirements: <ul><li>Minimum 6+ years of experience in the agricultural equipment/tractor implements industry.</li><li>Direct experience with tractor implements and attachments.</li><li>Ability to translate market needs and technical insights into product requirements and business recommendations.</li><li>Experience collaborating with Engineering, Suppliers, Quality, Sales, and other cross-functional teams.</li><li>Strong technical curiosity and ownership mindset.</li></ul>

Responsiblities: <ul><li>Design Quality Assurance: Organize and facilitate Design Reviews (DR) and DFMEA sessions to ensure robust product design and risk mitigation.</li><li>Prototype &amp; Sample Build Quality: Implement quality planning and controls for prototype/sample builds, including documentation and build record management.</li><li>Measurement System Validation: Conduct Measurement System Analysis (MSA) for inspection systems and gages used in the project.</li><li>Development Stage Quality Oversight: Analyze samples, address quality issues, and drive improvement actions during product development.</li><li>Verification &amp; Qualification: Lead design verification activities prior to design freeze and manage product qualification testing before Gate 5.</li><li>Tool &amp; Process Validation: Perform process capability studies and support Final Tool Approval (FTAR) using Comprehensive Tool Approval Reports (CTAR).</li><li>Production Quality Control: Establish and maintain quality controls and documentation for the production shop floor.</li><li>Ongoing Quality Monitoring: Monitor process capability and manage corrective actions to ensure sustained quality performance.</li><li>Inspection Review: Review and approve measurement and cosmetic inspection results to ensure compliance with specifications.</li><li>Audit Support: Provide support during customer and internal/external quality system audits.</li><li>Lead the development and implementation of Advanced Quality Planning (AQP) tools and methodologies within cross-functional product development teams.</li><li>Manage and mitigate project risks, ensuring customer requirements are clearly understood and integrated from the outset.</li><li>Conduct design and process audits for NPI projects, ensuring compliance with internal and external standards.</li><li>Collaborate closely with manufacturing sites to ensure seamless transition from design to production, including training facilitation and sharing of best practices and lessons learned.</li><li>Support customer complaint investigations during NPI, including documentation collection, in-process record review, and postmortem analysis.</li><li>Ensure effective deployment of control plans and support supplier development and management to meet quality expectations for NPI shipments.</li></ul> Requirements: <ul><li>Bachelor’s degree or higher in Electrical, Mechanical Engineering, or a related field.</li><li>Min 4 years experience in advanced quality</li><li>Proven quality control experience in cable assemblies, connectors, sockets, or related industries.</li><li>Strong understanding of ISO 9001 and APQP procedures.</li><li>Familiarity with EIA-364 test methods and internal/external auditing practices.</li><li>Knowledge of Model-Based Definition (MBD) and GD&amp;T requirements.</li><li>Proficient in Root Cause Analysis (8D, Fishbone, 5 Whys).</li><li>Skilled in Risk Management (DFMEA/PFMEA), Process Capability (Cp, Cpk, Pp, Ppk), and Tolerance Stack-Up Analysis.</li><li>Experienced in Design of Experiments (DOE) and Six Sigma methodologies (Black Belt preferred).</li><li>Competent in data analytics and visualization tools (Power BI, Tableau, Python/R).</li><li>Skilled in statistical software such as Minitab and JMP.</li><li>Strong organizational and strategic planning abilities.</li><li>Effective communicator with excellent written and verbal English skills.</li><li>Ability to mentor junior engineers and lead cross-functional teams.</li><li>Demonstrated capability in change management and driving continuous improvement.</li><li>Strong interpersonal skills for conflict resolution and stakeholder negotiation.</li><li>Committed to delivering high-quality solutions aligned with customer expectations and business strategy.</li></ul>

Responsibilities:&nbsp; The role will primarily involve: <ul><li>Reviewing legal content.</li><li>Structuring and validating legal content.</li><li>Translating legal content into Arabic.</li><li>Validating existing translations.</li><li>Conducting legal research and analysis.</li><li>The position is not focused on creating original legal content.&nbsp;</li><li>Instead, the emphasis is on translation, validation, review, and legal research activities.</li><li>Current expected workload is approximately 150 documents per month.</li></ul> Requirements: Law degree (LLB or equivalent legal qualification). <ul><li>Strong Arabic language proficiency, including:&nbsp;</li><li>Professional/native-level written Arabic.</li><li>Professional/native-level spoken Arabic.</li><li>Ability to read, interpret and analyze legal content in Arabic.</li><li>Fluent English communication skills.</li><li>Minimum 1 year of professional experience (flexibility to consider candidates with 6–12 months experience if they meet language and assessment requirements).</li></ul> Preferred Requirements <ul><li>South African citizens preferred.</li><li>Permanent residents in South Africa may also be considered.</li><li>Experience conducting legal research.</li><li>Experience drafting legal documents.</li></ul>

Responsibilities: <ul><li>Lead global standardization of Chemical and Slurry systems across manufacturing sites.</li><li>Act as Subject Matter Expert guiding engineering decisions and system architecture.</li><li>Drive technology roadmaps and long-term system strategies.</li><li>Lead design reviews, risk assessments, and engineering validation activities.</li><li>Provide technical oversight for complex facilities expansion projects.</li><li>Collaborate across global teams to ensure alignment and execution excellence.</li></ul> Requirements: <ul><li>Bachelor’s Degree in relevant engineering discipline.</li><li>Minimum 15+ years of semiconductor/facilities experience.</li><li>Advanced expertise in Chemical systems design and operation.</li><li>Strong background in slurry delivery, chemical distribution, and safety compliance.</li><li>Experience in system integration, process optimization, and reliability engineering.</li><li>Knowledge of construction and project lifecycle management.</li></ul>

Role Description: <ul><li>The Strategy team is looking for a hands-on AI-enabled strategy and market intelligence professional to materially accelerate the way we conduct deep research, market intelligence, analytical modeling, and GTM analysis by applying high impact AI workflows and translating them into sharper strategic decisions.</li><li>The individual will partner with business, product, commercial, and tech teams to translate ambiguous questions into actionable insights, while developing and scaling AI-enabled solutions that improve strategic decision-making and drive measurable business impact.&nbsp;</li><li>The individual is expected to work in close partnership with our client IT team, to leverage existing AI &amp; data capabilities on Databricks &amp; AWS (where applicable) while developing solutions.</li></ul> Responsibilities: Strategic problem solving and driving cross-functional execution&nbsp; <ul><li>Translate AI-assisted analyses into practical executive decisions by applying strong business judgment, rigorous validation protocols, and a sharp “so-what” orientation</li><li>Collaborate with and influence senior stakeholders across strategy, sales, technology teams, and P&amp;L owners</li><li>Good first-principles and problem-solving capabilities with the ability to build and test strategic hypotheses Identifying meaningful opportunities to leverage AI and deploying scaled AI solutions at pace</li></ul> Identify, assess, and prioritize high-value AI and automation opportunities by translating business challenges into scalable, practical solutions&nbsp; <ul><li>Design proprietary AI-enabled workflows, agents, and accelerators for recurring strategy activities (competitor monitoring, earnings call tracking, tariff and regulatory intelligence, voice-of-customer mining etc.)</li><li>Build reusable templates, workflows, and modules to drive adoption and embed AI capabilities into strategy processes</li></ul> Executing rapid AI-augmented research and competitive intelligence&nbsp; <ul><li>Lead AI-augmented research using tools like Claude, OpenAI, Perplexity, AlphaSense, CapIQ etc. to deliver source-triangulated competitive and industry insights</li><li>Synthesize structured datasets (S&amp;P Capital IQ, Bloomberg, IDC, Gartner) and unstructured sources (10-Ks, analyst reports, expert interviews) – to generate and validate AI-assisted outputs</li></ul> Support strategy team in day-to-day execution by leveraging AI-led tools <ul><li>Lead AI-enabled market sizing, opportunity mapping, and TAM/SAM/PAM modelling</li><li>Accelerate financial modelling – scenario and sensitivity analyses, valuation, NPV/IRR, segment P&amp;Ls, pricing</li><li>Support M&amp;A pipeline by AI-screening targets and generating investment theses</li></ul> AI enablement, coaching and continuous innovation <ul><li>Coach strategy team members on prompting techniques, research workflows, and AI-fluent execution</li><li>Scale AI adoption across Corporate Strategy through hands-on mentorship of beginner users</li><li>Stay current on agentic stacks, multimodal models, and deep research agents</li></ul> Requirements: Skillset and capabilities AI fluency and hands-on deployment orientation&nbsp; <ul><li>Working knowledge of GenAI patterns – LLM capabilities/limitations, prompt design, etc.</li><li>Proven ability to convert business problems into reusable AI workflows, tools, or accelerators</li><li>Builder mindset with experience prototyping AI solutions using frontier tools &amp; low-code platforms</li></ul> Analytics, modelling, and research excellence <ul><li>Strong modelling skills across TAM/SAM/PAM, scenarios, sensitivities, NPV/IRR, valuation etc.</li><li>Ability to synthesize structured datasets with unstructured sources</li><li>Research discipline – source triangulation and rigorous validation of AI outputs</li></ul> Strategic problem solving, communication, executive presence, and influence&nbsp; <ul><li>Sharp "so-what" orientation to translate AI outputs into practical executive decisions</li><li>Crisp written and verbal communication, with ability to frame board-ready narratives</li><li>Skill in explaining AI workflows and implications to both technical and non-technical audiences</li><li>Stakeholder management across strategy, commercial, data, and technology teams</li></ul> Ownership, and execution <ul><li>Independently own workstreams end-to-end – from framing through deployment</li><li>High bar for quality; never publishes unchecked AI outputs or unvalidated analysis</li></ul> Coaching and capability building&nbsp; <ul><li>Patience and ability to coach colleagues on prompting, research workflows, and source validation</li><li>Track record of building reusable playbooks – templates and training modules that scale adoption</li></ul> Passion, curiosity, and learning agility <ul><li>Deep passion for AI, tech, and industrial innovation, with curiosity to stay current on frontier tools</li><li>Entrepreneurial ownership mindset and drive to build a new AI-enabled strategy capability</li></ul> Qualifications:&nbsp; <ul><li>BE / B-Tech in Computer Science Engineering, Data Science or a related analytical field required; MBA, MS, M-Tech or equivalent advanced degree strongly preferred.</li><li>3–4+ years of experience in AI transformation, analytics, or AI-enabled business building. Prior Forward Deployed Engineer / Solutions Architect / Senior Data Scientist background preferred.</li><li>Experience in a top-tier strategy consulting firm, AI-native consulting team, analytics firm or corporate / product strategy team role strongly preferred.</li><li>Demonstrated experience building or deploying 0–1 AI solutions (not just experimenting), GenAI, analytics, automation, or workflow solutions in a business environment required.</li><li>Proficiency in Excel and PowerPoint required; Python or equivalent scripting capability strongly preferred. Experience with DevOps, CI/CD pipelines, and infra as code (e.g., Jenkins, Docker, Kubernetes) required.</li><li>Proficient in implementing AI platforms like AWS Bedrock, LangGraph, Crew AI, Glean etc.</li><li>Knowledge of enterprise data environments (esp. SAP, Databricks) or cloud platforms (esp. AWS) is a plus. Experience integrating AI systems with enterprise data platforms required.</li><li>Experience with LLM-powered solutions, RAG systems, agentic workflows, AI research tools, or AI-enabled knowledge manage</li></ul>

Responsibilities: <ul><li>Lead a global team of Advanced Quality Engineers in support of all new product introductions for a Strategic Product Line Portfolio within the Digital Data Networks (DDN) business unit. Lead all AQE activities from project inception to product launch and introduction.</li><li>Participate in the project Kick-off Meetings, support project team development for internal requirements, customer specific requirements, Risk Priority Number (RPN) reductions, analyze SPC data, etc.</li><li>Serve as the liaison between engineering and the plants on new product introductions to ensure robust process capability on all programs.</li><li>Attend project meetings and APQP driven events with the customers and the Project/Program Management Team.</li><li>Document the results for specific program characteristics and ensure the internal and external requirements are met including deviations.</li><li>Accountable for developing and driving on time delivery of Control Plans, Capability Studies, Part drawings, Inspection Instructions, Gage design and R&amp;R, DFMEAs, PFMEAs, AFMEAs for all assigned projects. Ensure the products developed are Designed for Manufacturing &amp; Assembly (DfMA) and are launched capably of meeting internal requirements and customer requirements.</li><li>Understand product requirements and define/approve Design Validation Test (DVT) and quality plans to ensure products meet the product specifications.</li><li>Authorize and approve that all Design Validation Test (DVT) results meet product specifications and customer requirements.</li><li>Actively participate in early product Concept Reviews and Design Review meetings with the Product Development Engineering (PDE) for the assigned product, related tooling and fixturing, and overall quality plans.</li><li>Generate and/or champion 8-Ds for the prototype process including 8-Ds for problem solving, test failures, and prototype failures.</li><li>Complete the Change Control process and identify special characteristics for projects/programs.</li><li>Work in conjunction with the Manufacturing Process Development Engineering (MPDE) teams to ensure the manufacturing process and equipment meets the product’s defined quality level and that the process also meets the capability levels identified for the product and project.</li><li>Assemble and submit PPAP package on time to the customer specific requirement.</li><li>Team with Supplier Quality Engineers to conduct and analyze process capability studies in support of Final Tool Approval (FTAR) for all tools and production lines associated with the project using the Comprehensive Tool Approval Report (CTAR), support completion of Supplier PPAPs.</li><li>Perform Six Sigma Capability Analysis of new equipment/processes to reduce variation.</li><li>Regularly reports to executive management on the overall performance and effectiveness of the Global Supplier Quality Program.</li><li>Drive high performance organization by providing your team routine coaching and feedback, holding your team accountable to meet performance objectives, and providing meaningful development to increase individual/team capability.</li><li>Manage employee well-being by prioritizing work, effectively managing resource loading, and providing flexibility to enable employees to successfully balance their work and personal lives.</li><li>Drive organization effectiveness by structuring your organization in a way that best enables the BU strategy, maximizes resource efficiency and productivity, and provides role clarity and clear lines of accountability.</li><li>Manage the talent in your organization to support the business now and to proactively prepare for the future by identifying organization skillset/role gaps, implementing plans to fill any skillset/role gaps, and assessing current talent fit to ensure the right talent is matched to the right roles to best meet the needs of the business.</li></ul> Requirements: <ul><li>Bachelor/ Master’s degree in technical discipline (Electrical Engineering, Electronics, Mechatronics)</li><li>10+ years of Experience in Quality, Advanced Quality Engineering, and working in global organizations.</li><li>Experience managing engineering teams in cross-functional, multi-site global organizations to drive effectiveness across geographical boundaries and deliver projects with multiple dependencies and constraints.</li><li>Demonstrated ability to forge strong internal working relationships with senior functional counterpart leaders.</li><li>Experience in the use of Lean, Six Sigma, Design for Six Sigma (DFSS), Design for Manufacturability &amp; Assembly (DfMA), Kaizen, 8D and other advanced statistical methods including Design of Experiments (DoE), Statistical Process Control (SPC) and Process Capability (CpK) analysis techniques.</li><li>Comprehensive knowledge and understanding of departmental, company, and corporate procedures and systems, i.e. ISO9000, ISO9001, IATF16949, ISO14001, VDA, PPAP, DFMEAs, PFMEAs, APQP Gate Reviews, GD&amp;T.</li><li>Excellent verbal and written communication skills and the ability to interact professionally with customers, leadership, stakeholders, cross functional teams and subject matter experts.</li><li>Proven track record of being able to work on multiple demanding programs in parallel while maintaining on-time completion of all defined project tasks and deliverables.</li><li>Ability to prioritize responsibilities in a fast-paced dynamic work environment.</li><li>Willingness to travel as required, ~30%</li></ul>

Responsibilities: <ul><li>Subject matter expert in signal integrity design, simulation and validation activities through product development cycles</li><li>Establishing signal integrity design performance/functional requirements for new products</li><li>Performing signal integrity simulations for multiple high-speed standards on each product. This includes determining the correct simulation methodology and setup to use, as well as a good understanding of the criteria for each interface.</li><li>Performing PCB design schematic and layout reviews</li><li>Creating actionable recommendations based upon design reviews and simulation results</li><li>Guiding connector design and component qualifications from a signal integrity standpoint. Making data driven decisions about the product functionality and areas for improvement.</li></ul> Requirements: <ul><li>Bachelor’s degree in Electrical Engineering.</li><li>Experience with interconnect design or experience with connector &amp;/or cable/cable assembly design (high speed twinax/RF cables, direct attach copper (DAC) cables)</li><li>Demonstrated experience using Signal integrity analysis tools (Agilent ADS, Ansys HFSS or equivalent)</li><li>A solid understanding of electromagnetic theory and electrical circuit behavior</li><li>Strong analytical capabilities to interpret simulation and lab data to identify issues and provide solutions to fix identified problem.</li><li>Familiarity with printed circuit board design, fabrication and assembly.</li><li>Excellent verbal and written communication skills</li><li>Ability to work in a global environment – able to accommodate varying time zones, fluent in English (verbal/written), able to collaborate with individuals across geographies</li><li>Solid presentation skills with an ability to clearly communicate technical concepts to diverse audiences in English</li><li>Individual must be highly motivated, a quick learner, and able to work independently</li></ul>

Responsibilities: <ul><li>Build comprehensive firmware verification plans for various firmware features.</li><li>Develop white/ grey-box, known, and closed system testing methods to verify and validate firmware products.</li><li>Analyze failures from weekly regressions and perform root-cause analysis, requiring deep SSD domain expertise.</li><li>Manage test development, test deployment, test automation, and reporting activities.</li><li>Communicate challenges, solutions, and mitigation plans to cross-functional teams and management with clear and effective communication of both technical and non-technical topics.</li><li>Participate in code reviews and guide the team to ensure comprehensive coverage and accurate architectural build.</li><li>Establish strong working relationships with firmware development engineers to improve code quality.</li><li>Lead a team of technical people, as required.</li></ul>&nbsp;Requirements: <ul><li>B.Sc. in Electrical Engineering, Computer Engineering, or Computer Science</li><li>6-8 years of pertinent experience in SSD firmware test development</li><li>Comprehensive understanding and substantial experience in SSD firmware testing and Python programming</li><li>Deep understanding of storage industry protocols such as PCIe, NVMe and NVMe-MI, with ability to design and develop tests aligned with specifications.</li><li>Familiarity with Agile/ Scrum development, GIT-based development workflow and branch management.</li><li>Experience with automated build, continuous integration, and test automation systems</li><li>Highly organized, creative, motivated, and passionate about achieving results</li><li>Ability to work on complex tasks independently with minimal supervision</li><li>Demonstrated leadership abilities and the capability to mentor less experienced engineers</li><li>Excellent problem-solving and analytical skills</li><li>Strong interpersonal and communication skills, and a great teammate</li></ul>

Responsibilities: <ul><li>Own and lead the process engineering function for cleanroom assembly, end-of-line test and pre-packing, ensuring safe, compliant and capable processes that meet cost, quality, safety and delivery targets.</li><li>Define department objectives, KPI dashboard and governance (e.g., NPI definition and handover lead times, first pass yields, failure rates, quality qppm) and drive execution through standard routines and reviews.</li><li>Lead, coach and develop a team of process engineers / technicians; set clear expectations, provide performance feedback, support competency development and ensure effective succession and talent retention.</li><li>Plan and manage resources (headcount, skills, priorities) to support daily manufacturing needs, escalations, and strategic projects; balance workload across product series and value streams.</li><li>Own process engineering deliverables for NPI or transfer projects: feasibility, process concept, capacity planning, industrialization roadmap, and readiness reviews to ensure on-time SOP.</li><li>Lead cross-functional collaboration with Product Design, Quality, Production, Maintenance, Supply Chain and global counterparts to deliver robust processes supported by Design for Manufacturing / Assembly / Test (DFM / DFA / DFT) improvements.</li><li>Own the strategy and budget for process equipment, tools, fixtures, testers and workstations; approve specifications, manage procurement, acceptance, validation and release to production.</li><li>Drive continuous improvement programs (CIP / Darwin) to improve throughput, cycle time, productivity and cost; support CIP events and ensure sustained gains through standardization.</li><li>Ensure effective utilization of PFMEA and other quality tools to manage and mitigate quality risks during process development, acceptance and production release.</li><li>Develop engineering procedures to govern end-to-end process engineering activities across process design, definition, industrialization, handover, sustainment and continuous improvements.&nbsp;</li><li>Ensure upkeep of process work instructions in D365 via Process Control System as per global standards, including revisioning control based on valid change management procedures.</li><li>Ensure robust management of engineering changes (ECR), process changes and deviations, including impact assessment, validation and controlled implementation.</li><li>Own 8D problem-solving governance for process-related issues, ensure timely root-cause containment / corrective and preventive actions, lessons learned, and clear communication to stakeholders.</li><li>Drive safety, ergonomics and regulatory / ISO compliance for process engineering scope; ensure safe equipment and process design through risk assessments.</li><li>Drive the sustainable deployment of state-of-the-art engineering solutions on the assembly shop floor to enhance quality control through robust error-proofing (poka‑yoke) mechanisms and digitalizations.</li><li>Act as the site focal point to align with global and process engineering counterparts on technology roadmaps, best practices and standardization.</li><li>Manage departmental reporting, change control and communication: provide clear status updates, risks and mitigation plans to operations and leadership.</li><li>Support ad hoc tasks as assigned by superior.</li></ul> Requirements: <ul><li>8–12+ years’ experience in manufacturing/precision mechanical assembly (high-mix preferred), with demonstrated ownership of end-to-end process engineering (process development/industrialization, cleaning / helium leak testing, and controlled-environment or cleanroom assembly where applicable).</li><li>Bachelor’s/Master’s degree in Mechanical, Manufacturing, Industrial Engineering or equivalent; formal training in Lean/Six Sigma and structured problem solving will be added advantage.</li><li>Proven people leadership experience (hiring, coaching, performance management) with the ability to lead technical teams and influence cross-functional stakeholders to deliver manufacturing results.</li><li>Strong written and spoken English communication skills, including the ability to produce clear technical documentation, present KPI performance, and communicate risks / mitigation to leadership.</li><li>Strong understanding of mechanical / pneumatic / electromechanical systems, process equipment and tooling, with experience defining specifications, commissioning, qualification / validation and release to production.</li><li>Demonstrated ownership and governance mindset - sets clear standards, drives disciplined execution, and maintains strong internal / external customer focus.</li><li>Strong prioritization, planning and project management skills to manage multiple workstreams (daily support, escalations, NPI, CIP) under tight timelines and resource constraints.</li><li>Strong technical acumen in quality planning processes especially in definition of process controls based on PFMEA.</li><li>Data-driven operational leadership: builds KPI dashboards, drives root-cause problem solving (8D / A3), and delivers sustained improvements in yield, throughput / cycle time and qppm.</li><li>Strong stakeholder management and change leadership - able to drive alignment across Production, Quality, Maintenance, Supply Chain and global counterparts; comfortable leading reviews and escalations.</li></ul>

Role Description: <ul><li>The Site Quality Leader is responsible for the administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions.&nbsp;</li><li>This position is responsible for ensuring full compliance to the regulatory requirements of 21 CFR 820, ISO13485, MDR and other applicable regulations including production and process controls.&nbsp;</li><li>The Site Quality Leader will report to the Global Head of Quality Operations.</li></ul> Responsibilities: <ul><li>Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.</li></ul>&nbsp;Develop and implement systems to assure that development as well as production teams receive support in the following areas: <ul><li>Quality planning, including inspection techniques and sampling methods</li><li>Statistical Analysis</li><li>Application of required regulatory standards</li></ul> Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum: <ul><li>Delivery of raw materials and components</li><li>Manufactured devices and equipment</li><li>Documentation associated with these functions</li><li>Develop, track, and report on the following administrative systems:</li><li>Department metrics</li><li>Department objectives</li><li>Personnel development and training</li><li>Support regulatory agency and customer quality audits.</li><li>Ensure the conformity of the components and products are appropriately checked in accordance with the Quality Management System before release.</li><li>Responsible for assisting and training associates in concepts of probability and statistics.</li><li>Responsible for failure appraisal and analysis (internal and external).</li><li>Authority to place products or processes on hold.</li><li>Design and develop forms and instructions for recording, evaluating, and reporting quality data.</li><li>Corrective and Preventive Action program</li><li>Based on operational/quality requirements, assist in test equipment selection and validation.</li><li>Utilize formal problem solving techniques to resolve product and/or process related issues.</li><li>As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.</li><li>Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.</li><li>Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations..</li></ul> Requirements: <ul><li>Bachelors Degree with a scientific or engineering emphasis.</li><li>ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.</li><li>7-10 years experience in a related regulatory environment.</li><li>Experience should include positions at senior levels within the medical device organizations.</li></ul>

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29 validation Jobs found

Product Specialist – Implements

Advanced Quality, Senior Engineer

Legal Analyst (Bilingual) Arabic & English

Staff Engineer – Chemical & Slurry Systems (Global Facilities Engineering)

Forward Deployed AI Strategist

Sr. Manager, Quality & Reliability Engineering

R&D/Product Dvl Engineer II

Principal/Staff, Firmware and Product Test (SSD)

Process Engineering Manager

Site Quality Leader

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29 validation Jobs found

Product Specialist – Implements

Advanced Quality, Senior Engineer

Legal Analyst (Bilingual) Arabic & English

Staff Engineer – Chemical & Slurry Systems (Global Facilities Engineering)

Forward Deployed AI Strategist

Sr. Manager, Quality & Reliability Engineering

R&D/Product Dvl Engineer II

Principal/Staff, Firmware and Product Test (SSD)

Process Engineering Manager

Site Quality Leader

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WhiteCrow is on a mission to connect companies with the best talent across the globe.