Senior Site Quality Manager

Validation Manager

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>

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>

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Senior Site Quality Manager

Validation Manager

Manufacturing Engineer

WET Process, Senior

Supplier Quality Engineer

Manufacturing Engineer

Facilities Engineer

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7 fmea Jobs found

Senior Site Quality Manager

Validation Manager

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.

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