Sr. Quality Engineer

Cooper Companies-posted 10 months ago
Full-time • Senior
Trumbull, CT
Real Estate
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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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options. CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

  • Development, implement, and maintain the company's QMS in accordance with relevant industry standards and regulations.
  • Analyzing quality data and generating reports to assess the performance of the quality management system and identify trends or areas for improvement.
  • Guide/Lead Quality Engineers as they continuously improve the manufacturing plant processes and procedures to meet Quality, Compliance and Business objectives.
  • Coach and mentor more junior level employees.
  • Trend Monthly Quality data (NCMR, CAPA, etc.) to ensure quality resources are being properly deployed to address the needs of the business.
  • Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems.
  • Coordinate and support Manufacturing Process Validation (VMP, IQ, OQ, PQ) to ensure all validation activities are in accordance with ISO 13485:2016, FDA 21 CFR Part 820, MDSAP and other applicable regulations.
  • Coordinate the execution of Measurement System Analysis Validations (MSA), as per business needs.
  • Support Validation activities during acquisition and transfer projects, as per site business needs.
  • Develop Process Failure Mode and Effect Analysis (pFMEA) to manage process risks.
  • Collaborate with teams to investigate and resolve quality issues, implement corrective actions to prevent recurrence, and verify effectiveness of actions.
  • Implement Lean and Six Sigma methodologies to streamline processes and reduce nonconformities.
  • Create and approve procedures and investigations to continuously improve site Quality Management System.
  • Monitor and communicate status of site KPI metrics for NCMRs, CAPA, and other QMS processes to the management.
  • Analyze information and come to conclusions based on presented data.
  • Communicate effectively both orally and in writing.
  • Demonstrate strong organizational and interpersonal skills.
  • Learn and utilize computer in standard business applications including electronic document control, word processing, spreadsheets, and databases.
  • Support external audits preparation and execution.
  • Bachelor's degree in a health, Engineering or Science field required; Advanced degree preferred.
  • Certified Lead Auditor ISO 13485:2016 is preferred.
  • ASQ or equivalent certification and/or relevant work experience is highly preferred.
  • Strong knowledge in Process validation (IQ/OQ/PQ/TMV/MSA).
  • Minimum of 10 years of experience in medical device or healthcare industry related experience.
  • 10+ years of quality systems background experience (NCMRs, CAPAs, Validations, Change Control, Training).
  • Minimum 10 years of experience managing external audits.
  • At least 10 years' experience in Quality Management/Quality Systems/ Audit Program Management.
  • Experience in integrations/acquisitions with respect to ensuring quality requirements are preserved pre-post integration.
  • Other Professional certification is an advantage (i.e, CQA, CQE, SQE, CQM, Etc).
  • Outstanding total compensation plan.
  • Medical coverage.
  • 401(k).
  • Parental leave.
  • Fertility benefits.
  • Paid time off for vacation, personal, sick and holidays.
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