Principal Quality Process Engineer

The Cooper Companies-posted about 2 months ago
Full-time • Mid Level
Trumbull, CT
5,001-10,000 employees
Miscellaneous Manufacturing
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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. 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.

  • Lead initiatives to maintain and improve the Quality Management System (QMS) in compliance with FDA Quality Systems Regulations (QSR), ISO 13485, EU MDR, and other applicable regulations.
  • Develop, implement, and maintain quality processes, procedures, and metrics to ensure consistent product quality and regulatory compliance.
  • Support internal and external audits, including but not limited to FDA, ISO, and notified body inspections.
  • Lead risk assessments (FMEA, Fault Tree Analysis) for new and existing processes.
  • Drive root cause analysis and corrective/preventive actions (CAPA) for process-related nonconformances and complaints.
  • Monitor and report on quality metrics and trends to identify areas for improvement.
  • Author and review controlled documents including SOPs, work instructions, validation protocols/reports, and engineering specifications.
  • Support change control processes for validated systems, equipment, and test methods.
  • Mentor and train junior engineers and quality staff on quality engineering principles and regulatory requirements.
  • Serve as a subject matter expert (SME) in quality process engineering during cross-functional meetings and project reviews.
  • Perform and participate in other projects at the discretion of management.
  • Proven experience with medical devices, combination products, and pharmaceuticals.
  • Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and EU MDR.
  • Expertise in process validation, statistical analysis, and quality tools.
  • Proficiency in quality software systems.
  • Strong analytical, problem-solving, and project management skills.
  • Excellent communication and leadership abilities.
  • Experience in Lean Six Sigma and Lean Manufacturing principles.
  • Minimum 10 years of experience in Quality Engineering or Process Engineering in the medical device and / or pharma industry.
  • Bachelor's degree in engineering (Mechanical, Biomedical, Industrial, or related field); master's degree preferred.
  • outstanding total compensation plan
  • great compensation package
  • medical coverage
  • 401(k)
  • parental leave
  • fertility benefits
  • paid time off for vacation, personal, sick and holidays
  • multiple other perks and benefits
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