Senior Supplier Quality Engineer- External Manufacturing

We need to output HTML fragment with sections only when there is real content. Use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must not repeat job title. We need to extract content. From posting: - About the role: The description includes "Scope: The Senior Supplier Quality Engineer (External Manufacturing) is responsible for providing quality oversight of external manufacturing and supplier quality." Also "Job Summary: ...". So we can combine into a paragraph. - Responsibilities: list of bullet points under "Responsibilities". Many bullet points. - Qualifications: includes "Qualifications Knowledge, Skills and Abilities:" then bullet-like list of knowledge, skills, abilities. Also "Experience:" and "Work Environment:" and "Education:" and "Certifications". Could be considered under Qualifications. The instruction: Use headings for sections like Qualifications, Skills, Benefits, Pay, Schedule. We have Qualifications and maybe Skills separate? The posting lumps knowledge, skills, abilities under Qualifications. Could separate Skills as a subsection? But we should only create sections when there is real specific content. We have content for Qualifications (knowledge, skills, abilities, experience, work environment, education, certifications). Could also have a Skills section if we extract skills. But we can keep Qualifications as one section covering all. - Benefits: "Our Benefits: As an employee ...". So we have Benefits. - Pay: "For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $100,000.00 - $125,000.00 annually." So we have Pay. - Schedule: Not mentioned. No schedule info. So we should not create Schedule section. - Also maybe "About the role" section. We need to remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we need to strip out the EEO statement, the agency note, etc. We need to preserve all substantive information. So we need to include the work location (Trumbull, CT or Livingston, NJ (hybrid)). That is part of About the role maybe. Also "Travel: This position may require up to 30% domestic and/or international travel." That could be part of About the role or Responsibilities? Probably About the role. We need to format using

headings,

• for any list of duties/requirements/benefits, and

  for prose. Thus:

  About the role

  CooperSurgical is a leading fertility and women’s healthcare company ... (the paragraph about company). Then include work location and scope and job summary and travel.

  But we need to avoid repeating job title. It's okay. We need to ensure we don't include boilerplate like "Learn more at www.coopersurgical.com". That's okay to keep? It's not boilerplate? It's a link but maybe considered navigation? It's not EEO. It's okay to keep. We need to remove the EEO statement and agency note. We need to keep the benefits paragraph. We need to keep pay paragraph. Now let's craft. First, gather About the role content: From posting: "About CooperSurgical JOB DESCRIPTION CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com . Work location: Trumbull, CT or Livingston, NJ (hybrid) Scope: The Senior Supplier Quality Engineer (External Manufacturing) is responsible for providing quality oversight of external manufacturing and supplier quality. Job Summary: The Senior Supplier Quality Engineer (External Manufacturing) is responsible for managing the external and contract manufacturing, ensuring that products manufactured by third‑party suppliers meet Cooper Surgical’s quality, regulatory, and performance standards. This role acts as the primary technical interface between CooperSurgical and its external suppliers, driving quality systems, leading issue resolution, and supporting continuous improvement across the supply base. Plays a critical role in supplier qualification, ongoing performance management, process validation, and ensuring compliance with internal standards and external regulations." Also Travel: "Travel: This position may require up to 30% domestic and/or international travel." We can combine into a paragraph. Now Responsibilities: list bullet points. We need to extract each responsibility line. From posting after "Responsibilities" heading: - Oversee the management of external manufacturing suppliers for development and execution of plans/strategies, and implementation of systems, processes, and procedures to ensure robust supplier/purchasing controls with regards to the determination, selection, qualification, monitoring, and disengagement of suppliers. - Lead routine operational quality reviews with external manufacturing partners to ensure ongoing compliance with quality system requirements, product specifications, and key operational metrics. - Provide day-to-day quality oversight of contract manufacturing operations, including batch record review, production monitoring, nonconformance management, and escalation of quality issues. - Review and trend quality data from external manufacturing sites, including deviations, scrap, yield, complaints, rework, and CAPA effectiveness, identifying opportunities for risk reduction and continuous improvement. - Approve suppliers based on risk, performance history, and alignment with business needs. - Lead PPAP/FAI reviews and ensure successful qualification of new products or components. - Proactively identify, develop, and lead the investigation and resolution of supplier-related challenges, and implement appropriate Quality Engineering methodologies, in support of supplier-related changes, risk management, to improve supplier reliability, minimize risks, and ensure sustainable material supply. - Provide SQ support to purchasing control audits of our external manufacturing sites. - Maintain supplier quality documentation, audit reports, and qualification packages. - Participate in Material Review Board (MRB) activities and support containment, rework and disposition decisions and defect prevention activities for nonconforming products and materials manufactured by external partners. - Review and approve process validation protocols (IQ/OQ/PQ). - Ensure adherence to control plans, PFMEA, and SOPs. - Support engineering changes, product transfers, tooling validation, and ramp‑ups. - Ensure change control processes are followed for materials, processes, and equipment. - Ensure all external manufacturing activities comply with industry regulations and organizational policies. - Support quality management reviews, audits, timely investigation of deviations, CAPAs and product disposition. - Support NPI products to align with R&D timelines, quality standards, and operational limitations. - Perform on-site quality oversight visits at contract manufacturing facilities to verify compliance, process adherence, operational controls, and execution of corrective actions Then after that there is "Performance Monitoring" subheading with more bullet points. Should we include those under Responsibilities as well? The instruction: Use
  • for any list of duties/requirements/benefits. So we can combine all duty-like bullet points under Responsibilities. The Performance Monitoring bullet points are also duties. So we should include them. Performance Monitoring bullet points: - Monitor manufacturing performance using Operational Excellence (OPEX) metrics as appropriate; provide regular updates to supply chain leadership - Ensure timely communication with third-party manufacturers regarding product forecasts, manufacturing, and delivery schedules. - Ensure adherence to terms in the Supply Agreement and Quality Agreement. - Provide regular updates and reports to the supply chain leadership. - Monitor and report supplier quality performance (PPM, defect trends, NCRs, OEE, delivery, Complaint rates, SCAR closure effectiveness). - Lead monthly/quarterly business reviews with key suppliers. - Develop and execute supplier improvement plans. - Manage scorecards and continuous improvement expectations. - Work as a liaison between the suppliers and Cooper Surgical team. We can include those as li under same ul. Now Qualifications: we need to extract knowledge, skills, abilities, experience, work environment, education, certifications. From posting: "Qualifications Knowledge, Skills and Abilities: Strong understanding of manufacturing processes (injection molding, machining, assembly, packaging, electronics, finished good manufacturing etc., depending on industry). Proficiency with quality tools: APQP, PPAP, FMEA, SPC, MSA, AQL. Ability to analyze data and interpret statistical trends. Experience with global manufacturing and supplier management. Familiarity with international regulatory requirements and market trends Strong communication and negotiation with external suppliers. Ability to influence without authority. Cross‑functional leadership and project management skills. Experience: 5+ years in supplier quality, external manufacturing, or process engineering or relevant experience. 7+ years in a regulated quality environment (medical device, pharma, life sciences). Experience working with global suppliers and contract manufacturers preferred. Work Environment: Manufacturing, clean room, warehouse, and office environments. May require extended periods of sitting, standing, and movement in production and supplier facilities. Education: Bachelor’s degree in engineering (Mechanical, Industrial, Manufacturing, Chemical, or equivalent) or equivalent experience or skillset. Certifications (Lead Auditor, ASQ CQE, Six Sigma Green/Black Belt) preferred." We can format as a list under Qualifications. But we might also separate Skills? The instruction includes Skills heading possible. However we have knowledge, skills, abilities already. Could create a Skills subsection but not required. We'll keep Qualifications as one section with list. Now Benefits: paragraph. Now Pay: paragraph. Now we need to ensure we don't include boilerplate: EEO statement, agency note, etc. Also remove duplicated lines: there may be duplicate sentences like "Provide regular updates and reports to the supply chain leadership." appears twice? Actually appears in Responsibilities and Performance Monitoring. We should keep both? It's duplicated content; we should remove duplicated lines. So we need to deduplicate. Let's list responsibilities and performance monitoring and see duplicates. Responsibilities list includes: 1. Oversee the management... 2. Lead routine operational quality reviews... 3. Provide day-to-day quality oversight... 4. Review and trend quality data... 5. Approve suppliers... 6. Lead PPAP/FAI reviews... 7. Proactively identify, develop, and lead the investigation... 8. Provide SQ support to purchasing control audits... 9. Maintain supplier quality documentation... 10. Participate in MRB activities... 11. Review and approve process validation protocols... 12. Ensure adherence to control plans, PFMEA, and SOPs. 13. Support engineering changes, product transfers, tooling validation, and ramp‑ups. 14. Ensure change control processes are followed for materials, processes, and equipment. 15. Ensure all external manufacturing activities comply with industry regulations and organizational policies. 16. Support quality management reviews, audits, timely investigation of deviations, CAPAs and product disposition. 17. Support NPI products to align with R&D timelines, quality standards, and operational limitations. 18. Perform on-site quality oversight visits... Performance Monitoring list: - Monitor manufacturing performance using OPEX metrics as appropriate; provide regular updates to supply chain leadership - Ensure timely communication with third-party manufacturers regarding product forecasts, manufacturing, and delivery schedules. - Ensure adherence to terms in the Supply Agreement and Quality Agreement. - Provide regular updates and reports to the supply chain leadership. - Monitor and report supplier quality performance (PPM, defect trends, NCRs, OEE, delivery, Complaint rates, SCAR closure effectiveness). - Lead monthly/quarterly business reviews with key suppliers. - Develop and execute supplier improvement plans. - Manage scorecards and continuous improvement expectations. - Work as a liaison between the suppliers and Cooper Surgical team. Duplicate: "Provide regular updates and reports to the supply chain leadership." appears in both lists (responsibility #? Actually not in responsibilities list; but appears in performance monitoring and also maybe in responsibilities? Not exactly. In responsibilities we have "Provide day-to-day quality oversight