Senior Quality & Reliability Engineer

Finance Business Partner

Senior Project Management Engineer

Manufacturing Manager / Staff Engineer - Cable Assembly

Manufacturing Manager / Staff Engineer - Cable Making

QC Lab Sample Coordinator

QE Specialist

Supv III Customer Service

Environmental Health and Safety (EHS) Manager

Supply Chain Business Process Expert

Responsibilities: Quality System &amp; Compliance <ul><li>Develop and implement quality and reliability processes to support NPI.</li><li>Lead the development and scaling of the site Quality Management System (QMS).</li><li>Ensure QMS elements (management reviews, internal audits, supplier management) comply with global standards.</li><li>Act as Lead Auditor for internal audits and ensure compliance with ISO 13485 and FDA QSR.</li><li>Support external audits, including preparation, mock audits, and corrective actions.</li><li>Review and approve ECOs, DCOs, training matrices, and other NPI documentation.</li><li>Maintain updated quality policies and procedures aligned with evolving standards.</li></ul> NPI Planning &amp; Execution <ul><li>Represent Quality in customer meetings and business reviews.</li><li>Collaborate with cross-functional teams including engineering, manufacturing, PMO, and supply chain.</li><li>Support implementation of electronic quality systems for improved traceability and documentation.</li><li>Evaluate product development objectives to identify quality improvement opportunities.</li><li>Create, review, and maintain quality system documents specific to NPI.</li><li>Calculate and present NPI quality KPIs.</li></ul> Continuous Improvement &amp; Problem Solving <ul><li>Lead or support quality system improvement projects.</li><li>Use statistical and scientific methods to analyze data and drive improvements.</li><li>Provide expertise in CAPA, root cause analysis, and reliability engineering tools.</li><li>Facilitate cross-functional improvement teams focused on NPI processes.</li></ul> Training &amp; Leadership <ul><li>Conduct training in GDP, GMP, CAPA, and compliance topics.</li><li>Oversee CAPA investigations to ensure true root cause identification and effective corrective actions.</li><li>Supervise and mentor Quality Engineers supporting NPI initiatives.</li></ul> Requirements: Required Skills &amp; Competencies Core Competencies <ul><li>Strong technical learning ability</li><li>Excellent problem-solving and analytical thinking</li><li>High ethical standards and integrity</li><li>Action-oriented and self-driven</li></ul> Job-Specific Skills <ul><li>Knowledge of NCMRs, CARs, CAPA, customer complaints, RMA metrics, DPPM, and DLPM</li><li>Strong technical "hands-on" skills</li><li>Excellent communication and interpersonal abilities</li><li>Ability to manage multiple tasks in a fast-paced environment</li><li>Strong prioritization and organizational skills</li><li>Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio)</li><li>Advanced technical report writing skills</li><li>Strong understanding of ISO 13485 and FDA QSR</li><li>Bilingual English (Advanced) / Spanish preferred</li><li>Willingness to travel up to 20% (based in Costa Rica)</li></ul> Experience &amp; Education <ul><li>Experience: 5+ years of Quality leadership experience in a manufacturing environment, preferably in multinational settings and NPI roles.</li><li>Education: Bachelor’s degree in a scientific or engineering discipline.</li><li>Certifications: CQE/CSSBB certification preferred.</li></ul>

Responsibilities: <ul><li>The Finance Business Partner, Operations will be providing timely, relevant and accurate information and insightful analysis to facilitate decision-making of senior management.</li><li>Developing the capability to drive swift data extraction and visualization bringing visibility and transparency of key business metrics.</li><li>Focused on finding meaningful insights to support continued and sustainable profitable growth of the our client business.</li><li>Drive improvement in the conversion cost and site fixed overhead vs budget and historical periods.</li><li>Also, bringing actionable insights, identity focus areas and run simulations for site management to optimize the cost level, in line with forecasted business activity.</li><li>Need monthly tracking and action monitoring, working collaboratively with site teams across different functions, and create visibility with global manufacturing team on the improvement actions.</li><li>Drive digital transformation journey of finance function and be instrumental in increasing utilization of BI tools, especially Power BI.</li><li>To include developing the dashboards and power query models required to achieve efficiency in data extraction and visualization.</li><li>Understand diverse internal and external data source and its architecture.</li><li>Able to integrate various data source for seamless automation of business analysis resulting in optimization of core financial workflows, enhancing efficiencies.</li><li>Able to perform analysis using large complex dataset, enhance the reports to improve performance tracking against targets and trend identification.</li><li>Effective contribution in annual budgeting and monthly forecasting process, such as developing templates for end-to-end budget planning and forecasting process.</li><li>Build and foster strong cross-functional relationships across business constituencies and stakeholders specially group support functions like Supply Chain, Manufacturing Ops and Procurement. Help the company understand how the pieces fit together to drive performance and strengthen the team’s partnership and influencing skills in pursuit of growth.</li><li>Price, Mix and Volume Analysis for Margin Improvements</li><li>Proactive participation in various business improvement/ad hoc projects.</li><li>Manages the overall Financial Reporting and Analysis activities in the production and delivery of all standard reporting (including template and chart updates), ad hoc reporting, presentation materials; and non-pricing / profitability (costing) analysis for the business, in accordance with defined standards.</li></ul> Requirements: <ul><li>At least 8-10 years’ work experience in Finance with at least 6 years’ experience in FP&amp;A</li><li>Experience working in manufacturing environment is a must</li><li>Strong business acumen.</li><li>Strong financial, technical, and quantitative analytical skills</li><li>In-depth knowledge of accounting principles, practices and regulatory issues and their application to a wide variety of areas</li><li>Ability to take ownership of a task or process, and see it through from inception to completion</li></ul> Preferred Skills <ul><li>Proven track record of developing and implementing value-added financial analysis</li><li>Self-awareness and ability to handle tight deadlines and manage complex business challenges</li><li>Demonstrated experience in analyzing and synthesizing complex financial data into meaningful executive summary statements</li><li>Excellent verbal and written skills, analytical thinker / problem solver, interpersonal skills, attention to details</li><li>Advance Excel skill, MS office and data management, Power BI skill is added advantage</li></ul> Key Relationships with Internal and External Stakeholders <ul><li>Operational Leadership</li><li>Site Finance Controllers</li><li>Group Finance Team</li><li>Site GMs and Operation team</li></ul> Additional Notes <ul><li>Sound financial knowledge with Chartered Accountant background</li></ul>

Responsibilities: Project Timeline: <ul><li>Identify and align projects goals and scope with PJM and PM, and breakdown tasks of tooling/process developments and qualification</li><li>Make/align tooling development and qualification timeline, assign tasks to Ops team include tooling development, materials purchase</li><li>Track and manage core team to execute project progress based on committed project schedule</li></ul> Project Cost: <ul><li>Lead Ops to simulate sample cost and production cost to achieve project landing zone target, lead Ops to optimize launch cost to the best</li><li>Budget and control scrap cost though leverage design and manufacturing process to meet project target during NPI phase</li></ul> Project Execution: <ul><li>Guide capacity planning, materials sourcing and manpower to support all builds in the plant.</li><li>Oversee the progression of tooling/process development, identify bottleneck and issues, organize Ops team to improve those bottleneck and issues.</li><li>Oversee risks assessment in project execution, stay interlock with PJM to make multigation plan and conduct the planned activities in Ops.</li><li>Finalize the Safe Launch plan for the appropriate mix of product, tool capability and demand with the approval of the PjM, Quality, MDPE, and PjE. a. Lead Safe Launch team meetings to assure successful HVM startup and manufacturing process qualification for attainment of required metrics for successful G5 handoff.</li><li>Align the budget with Ops team with the tooling list provided by MPDE-A, control total capital spending against CER.</li><li>Lead and coordinate line setup to conduct LVM sample builds and coordinate HVM tool builds.</li><li>Lead Ops to make ramp up plan, include materials, operations and tool capacity ramp up, ensure manufacture team take over production control smoothly after G5.</li></ul> Product Sustaining: <ul><li>Product migration, as a receiving or sending leader to execute product move in or move out, including project timeline, investment, cost control, machine/material/manpower preparation, safety stock, safe launch, etc.</li><li>Lead product capacity analysis and expand it through re-investment per estimation.</li></ul> Requirements: <ul><li>Bachelor degree, engineering background is better</li><li>PMP certification preferred</li><li>At least 5 years related working experience in project management, 1~2 years experience in connector/cable/cable assembly is better</li></ul>

Responsibilities: Planning and Budgeting: <ul><li>Develop and implement section budget and plan, and monitor the achievement of the budget in order to achieve targeted department performance.</li></ul> Policies and Procedures: <ul><li>Implement new global product development policies, procedures and systems; and maintain and develop local product development policies, procedures in order to meet company global requirements.</li></ul> People Management and Development: <ul><li>Allocate and balance the allocation of work across direct reports; review and provide timely performance feedback to direct reports; mentor, develop and motivate them; help resolve people/functional issues in the team in order to achieve targeted performance and retain key talent.</li></ul> Manufacturing Engineering: <ul><li>Develop advanced process technology; review automation project, tebit saving project; review new sample making reports; and provide technical support to key project in order to effectively support production and business development.</li></ul> Asset Management: <ul><li>Manage fixed asset and find new opportunity to reuse idle asset on new project in order to reduce product cost.</li></ul> Requirements: <ul><li>Bachelor degree with engineering and sciences</li><li>8-10 years cable assembly working experience including 4 years management experience.</li></ul>

Responsibilities: Planning and Budgeting: <ul><li>Develop and implement section budget and plan, and monitor the achievement of the budget in order to achieve targeted department performance.</li><li>Policies and Procedures</li><li>Implement new global product development policies, procedures and systems, and maintain and develop local product development policies, procedures in order to meet company global requirements.</li></ul> People Management and Development: <ul><li>Allocate and balance the allocation of work across direct reports, review and provide timely performance feedback to direct reports, mentor, develop and motivate them, help resolve people/functional issues in the team in order to achieve targeted performance and retain key talent.</li></ul> Product Design Engineering (Cable Making): <ul><li>Review product data reports(including drawings, BOM, routine, costs), review and approve new product design engineering programme and ECN(Engineering Change Notice) control in the system in order to support new business development.</li><li>Lead new product and new technology development program in order to meet the potential market demand.</li></ul> Project Management (Cable Making): <ul><li>Approve cable making new project proposal and allocate project/resources to PM, review projects progress and provide cross function coordination, attend design review meeting, and review and approve the release of final design in order to ensure successful project implementation."</li></ul> Cable Making Manufacturing Engineering:	 <ul><li>Develop cable making advanced process technology, review cable making machine design, supervise of new product pilot run including SOP (Standard Operation Process),</li><li>review new sample making reports, and provide technical support to key process problem solving in order to effectively support production and new cable business development</li></ul> Requirements: <ul><li>Bachelor degree with engineering and sciences</li><li>8 years cable making working experience including 4 years management experience.</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC sample/reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC sample reconciliation and disposal.</li><li>Tracks inventory of product samples, stability samples, and test materials in the lab.</li><li>Uses laboratory software for sample, reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with samples.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Send samples for outside testing. Submit samples to the appropriate labs for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the submission of samples.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting sample processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations&nbsp; <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any sample and reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance&nbsp; <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendia requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computer savvy.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.</li><li>Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>Provide real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.</li><li>Perform batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.</li><li>Execute and document line clearance and room readiness inspections prior to manufacturing activities.</li><li>Review qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated. 6.	Initiate, investigate, and support closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.</li><li>Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.</li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Participate in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.</li><li>Support the implementation of continuous improvement initiatives and site quality metrics.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>2–5 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities is strongly preferred</li><li>Familiarity with GDP, batch record review, and deviation documentation processes</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>Comfortable supporting shop-floor activities and cross-functional execution teams</li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

Role Description: <ul><li>As a Manager in Solution Center, you will be at the forefront of driving transformational strategies focused on creating exceptional customer experiences.</li><li>Your leadership will be pivotal in establishing our brand as the preferred supplier by fostering strong customer relationships and steering your team towards unparalleled service excellence and growth.</li></ul> Responsibilities: <ul><li>Lead with Accountability: Spearhead your team to achieve specific departmental goals, focusing on delivering a superior Customer Experience.</li><li>Cultivate Customer Relationships: Empower your team to enhance and expand customer engagement.</li><li>Talent Acquisition and Development: Recruit and nurture top talent, building a team that embodies our vision and drives organizational transformation.</li><li>Champion of Change: Lead by example in adopting transformation initiatives and fostering a culture of positive change.</li><li>Operational Excellence: Instill a mindset of continuous improvement, enhancing team efficiency and service quality.</li><li>Career Development: Offer opportunities for team growth and development, preparing them for future career advancements.</li><li>Cross-Functional Collaboration: Work seamlessly with internal partners in different BU’s, engineering, planning, and sales to ensure comprehensive customer support.</li></ul> Requirements: <ul><li>Experience in a shared service environment.</li><li>Stake Holder management experience</li><li>Track record of successful change management in Customer Care.</li><li>Leadership experience in large, multi-layered teams.</li><li>8 + years in multinational Customer Care operations, with at least 5 years in a relevant role.</li><li>Effective collaboration across all organizational levels.</li><li>Industry-specific experience is advantageous.</li><li>Exceptional communication skills.</li></ul>

Responsibilites: <ul><li>Develop and implement site-wide EHS programs aligned with federal, state, and local regulations, including OSHA, EPA, and DEA requirements for controlled substances.</li><li>Lead risk assessments, job hazard analyses (JHAs), and containment evaluations, particularly in areas handling high-potent and controlled substances.</li><li>Serve as the primary liaison for EHS-related aspects of DEA compliance, supporting controlled substance handling protocols in collaboration with Quality, Security, and Operations.</li><li>Oversee the environmental and safety controls for controlled substances, ensuring proper ventilation, storage, access restrictions, spill response, and waste disposal procedures in compliance with DEA and EPA regulations.</li><li>Develop and maintain physical and procedural controls related to controlled substance areas (e.g., vaults, restricted labs, destruction processes) in partnership with Security and Regulatory Affairs.</li><li>Lead the investigation and root cause analysis of all incidents, near-misses, and controlled substance discrepancies, and implement corrective/preventive actions.</li><li>Ensure training and education of site personnel in EHS best practices, with a focus on potent compound safety, exposure monitoring, and controlled substance handling protocols.</li><li>Implement industrial hygiene programs, including monitoring of airborne concentrations and potential operator exposure to potent and hazardous compounds.</li><li>Establish robust programs for emergency preparedness, including chemical spills, fires, security threats, and controlled substance incidents.</li><li>Maintain all required permits, records, and documentation related to hazardous waste, emissions, safety incidents, and controlled substance EHS compliance.</li><li>Partner with Engineering, Validation, and Operations to incorporate EHS and security standards into facility, utility, and equipment design and commissioning.</li><li>Foster a strong culture of safety, accountability, and environmental stewardship at all levels of the organization.</li></ul> Requirements: <ul><li>Bachelor’s degree in Environmental Science, Occupational Health &amp; Safety, Chemical Engineering, or related field (Master’s preferred).</li><li>Minimum of 7–10 years of progressive EHS experience in a GMP-regulated pharmaceutical or biotechnology manufacturing environment.</li><li>Direct experience managing EHS compliance for controlled substances (DEA Schedules II–V) and high-potency APIs strongly preferred.</li><li>In-depth knowledge of OSHA, EPA, DEA, NJDEP, and global EHS regulations and guidelines.</li><li>Familiarity with industrial hygiene, containment technologies, and safe handling procedures for potent compounds</li><li>Experience leading EHS activities during greenfield/startup site development and qualification is a plus.</li></ul>

Role Description: <ul><li>As a member of our ISC Global Automotive team, you will focus on enhancing our S&amp;OE process and driving the successful implementation of SAP APO PP/DS or S4 ePPDS as well as SAP IBP in our manufacturing plants.</li><li>Leveraging your extensive experience with advanced planning software, you will help define business requirements, ensure system readiness, and guide local teams through adoption and optimization processes.</li></ul> Responsibilities: <ul><li>Drive initiatives in automation and advanced planning systems to enhance and refine S&amp;OE processes.</li><li>Lead cross-functional teams - including project managers, subject matter experts, and IT partners - in defining business requirements, designing.</li><li>Provide project updates to various stakeholders at different levels of the organization.</li><li>Focus on timely project completion, resource deployment, staying within budget and appropriate adoption by end users.</li><li>Develop comprehensive training materials for end users and deliver training sessions and champion best practices and contribute to the development of standardized processes</li></ul> Requirements: <ul><li>Master’s degree or equivalent in Supply Chain, Materials Management, Business, Logistics, Engineering, or related field.</li><li>5 years’ hands-on experience in supply chain and operations, ideally manufacturing planning.&nbsp;</li><li>Extensive user-side experience in SAP APO PP/DS or S4 ePPDS implementation (essential); experience with SAP IBP Response is highly desirable.</li><li>Proven ability to use and train others on APO PP/DS and/or S4 ePPDS tools.</li></ul>

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222 functional safety manager Jobs found

Senior Quality & Reliability Engineer

Finance Business Partner

Senior Project Management Engineer

Manufacturing Manager / Staff Engineer - Cable Assembly

Manufacturing Manager / Staff Engineer - Cable Making

QC Lab Sample Coordinator

QE Specialist

Supv III Customer Service

Environmental Health and Safety (EHS) Manager

Supply Chain Business Process Expert

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222 functional safety manager Jobs found

Senior Quality & Reliability Engineer

Finance Business Partner

Senior Project Management Engineer

Manufacturing Manager / Staff Engineer - Cable Assembly

Manufacturing Manager / Staff Engineer - Cable Making

QC Lab Sample Coordinator

QE Specialist

Supv III Customer Service

Environmental Health and Safety (EHS) Manager

Supply Chain Business Process Expert

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

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