Senior Site Quality Manager

Validation Manager

Sr R&D/Product DVL Engineer

Quality Senior Lead

Manufacturing Engineer

WET Process, Senior

Supplier Quality Engineer 

Facilities Engineer

Responsibilities: <ul><li>Lead and develop the quality team, fostering a culture of continuous improvement and cross-department collaboration.</li><li>Partner with manufacturing, engineering, and global quality teams to ensure product quality, process capability, and regulatory compliance.</li><li>Champion and uphold plant-wide quality standards, policies, and systems in alignment with corporate and customer requirements.</li><li>Monitor and report key quality performance indicators (e.g., customer complaints, internal defects) and provide actionable insights to plant leadership.</li><li>Manage internal and external audits and ensure audit readiness across the facility.</li><li>Oversee plant-wide quality improvement initiatives to reduce defects and scrap and improve process control and product reliability.</li><li>Lead root cause analysis, corrective actions, and continuous improvement efforts to address recurring quality issues.</li><li>Collaborate with engineering and production teams to ensure new product introduction (NPI) meets quality standards.</li><li>Mentor and coach quality team members to foster a high-performance culture.</li><li>Travel as required to support internal and external customer needs and NPI programs.</li></ul> Requirements: <ul><li>Bachelor’s degree in Engineering, Quality, or a related technical field (preferred).</li><li>8+ years of progressive quality experience in a manufacturing environment.</li><li>Strong knowledge of ISO 9001 and regulatory compliance standards.</li><li>Minimum of 3 years in a leadership role managing quality teams.</li><li>Expertise in Lean Manufacturing and advanced quality methodologies.</li><li>Proven experience with 8D problem solving, FMEA, DOE, SPC, and safe launch processes.</li><li>Proficiency in quality data analysis tools such as Minitab, JMP, or similar.</li><li>Excellent communication, analytical, and leadership skills, with the ability to inspire and motivate teams.</li></ul>

Responsibilities: <ul><li>Serve as the site Validation SME, overseeing all validation activities, including process, cleaning, equipment, utility, and computer system validation.</li><li>Own and maintain the Validation Master Plan (VMP), ensuring alignment with regulatory expectations, site activities, and company objectives.</li><li>Develop, implement, and maintain the site validation lifecycle program, including process validation, performance qualification (PQ), and CPV.</li><li>Lead validation planning and coordination efforts for new equipment, systems, and process changes in collaboration with Engineering, Manufacturing, and Quality.</li><li>Manage validation project timelines and resource allocation, ensuring activities support commercial readiness and ongoing operations.</li><li>Review and approve validation protocols, reports, and risk assessments in compliance with FDA, EMA, ICH Q8-Q10, EU Annex 15, and company standards.</li><li>Support and participate in cross-functional risk assessments (e.g., FMEA) related to qualification and validation efforts.</li><li>Ensure validation documentation is complete, accurate, and audit ready.</li><li>Provide guidance and technical expertise during regulatory inspections, audits, and customer assessments.</li><li>Develop and maintain the site’s Continuous Process Verification (CPV) program to monitor validated state and process performance over time.</li><li>Define and monitor KPIs for validation program effectiveness and drive improvements in validation efficiency and compliance.</li><li>Train and mentor staff on validation principles and procedures to build internal capability across departments.</li><li>Ensure change control, deviation management, and CAPA processes integrate appropriately with validation and qualification requirements.&nbsp;</li></ul> Key Stakeholders: Internal: <ul><li>Site Quality, Manufacturing, and Engineering Teams</li><li>Technical Services, Supply Chain, and EHS</li><li>Validation Analysts and Support Staff</li><li>Corporate Validation and Quality Teams</li></ul> External: <ul><li>Regulatory Agencies (FDA, EMA, etc.)</li><li>Equipment and system vendors</li><li>Contract testing laboratories</li><li>Third-party auditors and certifying bodies</li></ul> Requirements; Qualifications / Experience: <ul><li>Bachelor’s degree in engineering, Life Sciences, Pharmacy, or related discipline; Master’s preferred</li><li>Minimum 10-12 years of experience in pharmaceutical or biotechnology validation, with at least 3 years in a leadership or SME role</li><li>Validation of sterile injectable equipment expertise required</li><li>Strong knowledge of FDA cGMPs, ICH Q8–Q10, EU Annex 15, and validation best practices</li><li>Experience with sterile injectable manufacturing, aseptic processes, utilities, and equipment qualification</li><li>Experience with controlled substances and high-potency compounds preferred</li><li>Proven experience supporting regulatory inspections and third-party audits</li><li>Experience with commissioning, qualification, and validation in a startup (greenfield) or expansion environment preferred </li></ul> Skills / Competencies: <ul><li>Strong technical writing and documentation review skills</li><li>Ability to manage multiple projects and prioritize in a fast-paced environment</li><li>Expertise in sterile systems, process validation, cleaning validation, and computer system validation</li><li>Excellent cross-functional communication, influencing, and collaboration skills</li><li>Strong analytical, risk-based decision-making, and problem-solving skills</li><li>Leadership presence with ability to coach and mentor others in validation principles</li><li>Commitment to data integrity, patient safety, and product quality</li></ul>

Role Description: <ul><li>As Sr R&amp;D/PRODUCT DVL ENGINEER in Digital Data &amp; Networks (DDN) Business Unit, you will work in a global sustaining engineering team responsible for the continued support and evolution of production parts and products throughout their lifecycle.</li><li>This includes driving product lifecycle management, product extensions, rapid NPIs, VAVE initiatives, sustainability improvements, material and process changes, and manufacturing location transfers.</li><li>The role also involves providing technical support to plants, suppliers, and customers to ensure continuity, quality, and cost optimization.&nbsp;</li></ul> Responsibilities: <ul><li>Responsible for sustaining activities for the Antenna, RF, COAX cable and connector product lines.</li><li>Execute critical engineering projects, including manufacturing transfers, sustaining, product extensions, cost reduction (VAVE), sustainability and rapid New Product Introduction.</li><li>Represent engineering in customer meetings, project meetings and site visits, providing technical support and insights as needed.</li><li>Support the complete product life cycle (Design updates, Creation of product specifications, 3D/2D modeling, Prototyping, Product testing, Product qualification, Project Execution &amp; Sustaining till product end of life).</li><li>Work closely with PM and other cross functions in getting the right and clear requirements to make engineering evaluation/proposal to update the design.&nbsp;</li><li>Follow sustaining Project Process to support project team from PDE perspective to complete Project on time, quality and budget.</li><li>Technical support for customers, sales, PM and plant team. Define &amp; coordinate with test lab for necessary qualification testing, engineering analysis, trouble shooting and verification.&nbsp;</li><li>Apply engineering is the best practice to reduce costs and sustain exiting products to meet customers’ cost targets.</li><li>2D &amp; 3D drawing creation (Creo and SolidWorks Preferred) and release as per our client and procedures through ECR/ECN/PCN processes.</li></ul> Requirements: <ul><li>Bachelor’s degree in mechanical, or a related Engineering discipline; advanced degree preferred.</li><li>8+ years working experience as new product development or sustaining engineering related positions including 3+ years of working experience on product development of Antenna, RF, COAX cable and connector.</li><li>Strong foundation in mechanical engineering principles with proven application in product development.</li><li>This position is highly technical and requires an individual who can work independently.</li><li>Understanding product compliance certification and qualification testing.&nbsp;</li><li>Experience in design for manufacturing and assembly (DFMA), design for cost (DFC), design for manufacturing (DFM)</li><li>Demonstrated problem-solving and root cause analysis.</li><li>Proven expertise in sustaining engineering and product lifecycle support, including design enhancements, prototyping, testing, and cost/productivity improvements (VAVE).</li><li>Understanding of product lifecycle management (PLM) and new product development (NPD) processes.</li><li>Hands-on experience with modern design and analysis tools including 3D CAD, modeling, Geometric Dimensioning &amp; Tolerancing (GD&amp;T), and simulation tools.</li><li>Knowledge of manufacturing processes such as machining, molding, stamping, and plating.</li><li>Basic understanding of quality tools and methodologies such as FMEA, Six Sigma, DOE, 8D, etc.</li></ul>

Role Description: <ul><li>Work with Parts leadership team to develop Quality system for Parts operations and implement.</li><li>Drive quality improvements in Receiving, storage, Packaging and shipping.</li><li>The position will be responsible for both Product quality and process quality.</li><li>The position will also oversee quality awareness program to educate and empower teams to drive quality function in their departments.</li></ul> Responsibilities: <ul><li>Develop and implement robust quality assurance processes for incoming, in-process, and outgoing tractor spare parts.</li><li>Conduct inspections and audits to ensure adherence to company and industry standards using Demerit system.</li><li>Collaborate with suppliers to maintain the quality of purchased parts.</li><li>Manage dealer return and claim management including issuance of credit notes to customers.</li><li>Drive quality awareness program to improve skill levels of warehouse teams with respect to Quality.</li><li>Mistake proof processes to ensure zero defects flowing to customer.</li></ul> Requiresments: <ul><li>Quality management experience of 2 – 3 years is preferred</li><li>Experience / exposure to best practices for packaging of spare parts in warehousing environment.</li><li>Exposure and experience in use of quality tools like APQP, FMEA, and SPC will be plus.</li><li>Understanding of Lean six Sigma Principles</li><li>Must be Proficient in Microsoft Excel, Outlook and SAP</li><li>Excellent data analysis skills and analytical mindset</li><li>Ability to work in a team environment</li><li>Excellent communication skills.</li><li>Ability to read, write, and speak the English language is required.</li><li>Bilingual (Spanish) is a plus</li><li>While performing the duties of this job, the employee is frequently required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear.</li><li>The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl.</li></ul>

Responsibilities: <ul><li>Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.</li><li>Provide technical support for new product introduction (NPI), including process design, tooling, and equipment validation.</li><li>Conduct root cause analysis and lead corrective/preventive actions (CAPA) to&nbsp;</li><li>resolve production issues.</li><li>Collaborate with cross-functional teams (R&amp;D, Quality, Supply Chain, Maintenance) to ensure smooth project execution and production readiness.</li><li>Prepare and maintain process documentation, work instructions, and training materials.</li><li>Monitor key production metrics (yield, scrap, cycle time, downtime) and implement continuous improvement initiatives.</li><li>Participate in lean manufacturing, Six Sigma, and Kaizen activities to drive operational excellence.</li><li>Ensure compliance with safety standards, environmental regulations, and ISO/IATF quality system requirements.</li><li>Support cost reduction projects through process improvement, automation, and supplier collaboration.</li></ul> Requirements: <ul><li>Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field.</li><li>3–5 years of relevant experience in manufacturing engineering; automotive or electronics industry experience preferred.</li><li>Strong knowledge of manufacturing processes such as machining, assembly, injection molding, stamping, or PCB assembly (depending on industry).</li><li>Familiarity with APQP, PPAP, FMEA, Control Plan, and other quality tools.</li><li>Proficiency in CAD software (e.g., AutoCAD, SolidWorks, Creo) and MS Office.</li><li>Hands-on experience with Lean Manufacturing and problem-solving methodologies (5Why, 8D, DMAIC).</li><li>Good communication and coordination skills; able to work in cross-functional and multicultural teams.</li><li>English: able to read and write technical documents; spoken English is a plus.</li></ul>

Responsibilities: <ul><li>Drive cost reduction, weed out unwarranted expenses/wastages, find alternative sources and improve processes with innovative solutions to raise efficiency.</li><li>Drive quality investigations and continuous improvement programs to resolve chronic process and quality issues, and institute permanent resolutions to assure product quality and enhance process robustness.</li><li>Enforce on line controls and execution to conform to work instructions and procedures.&nbsp;</li><li>Apply hands-on and with deep involvement at work.</li><li>Coach, guide and train engineers and technicians in processes and problem solving and analysis to build up their technical competencies and achieve self-sustenance.</li><li>Take accountability of work and possesses strong sense of responsibility and team work.</li><li>Ensure non-conformance is dealt with in a proper and effective manner.</li><li>Establish, review and perform regular update of FMEA, OCAP, Process control, Risk Assessment and SIPOC on all critical processes to ensure a robust process.</li><li>Compliance with CSR, EHS, QM, ESD, 5S standard and cleanroom protocol.</li></ul> Requirements: <ul><li>Relevant knowledge of WET process and Semi-conductor WET equipment –SRD , WET Bench , WET etch , High pressure clean etc.</li><li>Able to identify cheaper source Chemical suppliers and Qualify new chemicals</li><li>Strong organizational, leadership, communications and interpersonal skills.</li><li>Systematic troubleshooting and problem-solving skills.</li><li>Application of quality and SPC tools at work.</li><li>Dynamic, resourceful, creative, innovative and self-driven.</li><li>A strong analytical mind and able to organize works to identify the root cause of problems.&nbsp;</li><li>Able to multi-task, set priorities and meet deadlines.</li></ul>

Responsibilities: <ul><li>Quality Key Contact and Account owner for assigned suppliers.</li><li>Owner of supplier quality performance for assigned suppliers and commodity.</li><li>Organize and Perform Suppliers Scorecard Reviews, Business Reviews, Complaint reviews and other management reviews.</li><li>Quality representative on Sourcing decisions</li><li>Participate / Leads Audits at suppliers (Systematic, process, etc.) per the Annual Audit Plan or Problem-Solving activities. Performs new supplier qualification audit when SDE function is not available in the region.</li><li>Owner of supplier 8D (D4~D8) and 8D quality rating.</li><li>Supports IQE on Complaint Handling for the assigned suppliers (as Escalation step for IQE)</li><li>Define and track Performance Agreements.</li><li>Supplier improvement – Participate in 6-Sigma lean projects, Kaizen events, Quality Improvement Plan activities (CoPQ, CCR, SATI etc.).</li><li>Supplier Training – Provide Technical aid and Training to suppliers when necessary to achieve the required Quality level in collaboration with SDE if needed.</li><li>Contributes to Lessons Learned documents in collaboration with other supplier quality.</li></ul> Requirements: <ul><li>At least 5 years of experience within connector and cable assembly Quality</li><li>Expert Knowledge on ISO9001. Preferred on IATF16949, ISO 14000 and other industry standards</li><li>Certified ISO 9001 auditor by the 2nd party auditor</li><li>Demonstrated skills in a matrix environment</li><li>Working Knowledge on specific product and process as needed (e.g., Molding, Stamping, PCB/PCBA, diecasting, bulk cable …)</li><li>Be familiar with the tools related to supplier APQP process, include but not limit to APQP, PPAP, FMEA, CP, MSA, SPC, R@R and 8D.</li><li>Ability to work across cultures and countries effectively.</li><li>Thorough knowledge of Problem-Solving tools</li><li>Process Auditor Skills mandatory</li><li>SAP basic knowledge</li><li>Knowledge in GD&amp;T and Advance knowledge reading technical drawings and specifications</li><li>Presentation skills</li><li>Communication and negotiation skills</li><li>Coaching skills</li></ul>

Responsibilities: New Project: In order to ensure that the mass production project can meet the production requirements and achieve the purpose of on-time delivery: <ul><li>Design and improve the mass production expansion PN assembly equipment, FSR sample production and inspection</li><li>Follow up the mass production project to expand P/N samples and expand business, and make external sample requirements</li><li>Guide technicians to debug assembly equipment and make samples</li><li>Take safety protection measures and implement the companys EHS standards and requirements</li></ul> Production Problem Handling: In order to ensure the normal operation of daily production, reduce scrap and downtime: <ul><li>Track and analyze production engineering problems and provide solutions</li><li>Guide technicians to solve production engineering problems</li><li>Cooperate with QE to jointly handle customer quality complaints</li></ul> Production process improvement: In order to improve production efficiency and reduce costs: <ul><li>Find improvement points, formulate improvement plans and implement improvement actions with other relevant departments</li><li>Communicate with ECO in a timely manner about improvements in product design</li></ul> Production equipment repair and maintenance: In order to ensure the good operation and safety of production equipment and molds: <ul><li>Formulate equipment and mold repair, maintenance and overhaul plans and supervise technicians to implement</li><li>Check the safety protection devices of the equipment and implement the companys EHS standards and requirements</li></ul> Production Document Preparation and Management: To ensure the completeness and timeliness of production documents: <ul><li>Prepare and update engineering documents (such as work instructions, production flow charts, FMEA, etc.)</li><li>Follow up and implement engineering changes</li></ul> Requirements: Education, Technical Qualification &amp; Experience: <ul><li>Bachelor degree or above Mechanical/engineering related major</li><li>5 years of relevant work experience CET-4</li></ul>

Responsibilities: <ul><li>Responsible for system operation including cleanroom, MAU, Dry Coil, FFU, AHU, CDA, Process Vacuum, PCW, Chiller, Cooling tower, Pumps System, Acid Scrubbers &amp; Exhaust system, Solvent Exhaust, General Exhaust system, Calamity Exhaust system, Fire protection and fire alarm system, air conditioning, etc.</li><li>Develop, maintain and review operational &amp; maintenance procedure and ensure facilities equipment operate in optimum level (efficiency, healthy, safe, etc.) together with Plant Facilities.</li><li>Review predictive and preventive maintenance of the system for continuous improvement together with Operation &amp; Maintenance.</li><li>Evaluate and review system operation/design to reduce cost and improve system reliability.</li><li>Support, coach and guide technicians in operation &amp; maintenance, troubleshooting, etc.</li><li>Interface with Engineering, Operation, EHS for equipment, preventative/correction maintenance program and projects and compliance with various regulatory procedures.</li><li>Ensure good documentation (hardcopy and softcopy) of facilities system</li><li>Aspect impact, FMEA, SDS, risk assessment, control plan&nbsp;</li></ul> Mechanical Facilities System Capacity Management: <ul><li>Capacity Review</li><li>Drawing Management</li></ul> Responsible for Mechanical Facilities System Training: <ul><li>Develop and maintain training material:</li></ul> Conduct training: <ul><li>Responsible for Mechanical System Maintenance. Review maintenance contract to ensure adequate maintenance suit to facilities system.</li><li>Work Order Support to close all defects and issues on time.</li><li>Facilities Projects Support – Infrastructure/Clean room/Facilities System (Upgrade, Expansion, Modification, Retrofit, Improvement, Robustness, Energy Saving, etc.)</li><li>Feasibilities Studies and Technical Review for Projects</li><li>Project Specification Preparation</li><li>Project Execution</li><li>Project Buy-Off</li><li>Facilities Expansion Plan</li></ul> Manufacturing Support: <ul><li>Plan and execute Facilities POU Readiness for Equipment hookup</li><li>Support in Equipment hookup&nbsp;</li><li>Work with Equipment, Process Engineering, Production, Industrial Engineering, EHS, etc. on operation issue/expansion projects/improvement projects/etc.</li></ul> Requirements: <ul><li>Degree holder preferable in Engineering or equivalent.</li><li>Min. 3 years in similar capacity and working experience in related field</li><li>Ability to work on multiple tasks and projects concurrently</li><li>Self-motivated and able to work independently</li></ul>

Skills

Industry

Location

Jobtitle

9 fmea Jobs found

Senior Site Quality Manager

Validation Manager

Sr R&D/Product DVL Engineer

Quality Senior Lead

Manufacturing Engineer

WET Process, Senior

Supplier Quality Engineer

Manufacturing Engineer

Facilities Engineer

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

Skills

Industry

Location

Jobtitle

9 fmea Jobs found

Senior Site Quality Manager

Validation Manager

Sr R&D/Product DVL Engineer

Quality Senior Lead

Manufacturing Engineer

WET Process, Senior

Supplier Quality Engineer

Manufacturing Engineer

Facilities Engineer

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

JOBS BY LOCATIONS

MODEL JOBS

JOBS BY CITY

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