Senior Manager Supplier Quality

2 weeks ago

Trumbull, Connecticut, United States CooperSurgical Full time
About the Role

The Senior Manager, Supplier Quality is a critical leadership position responsible for overseeing the quality management of suppliers and service providers supporting the CooperSurgical organization. This role requires a strong understanding of quality systems, regulatory requirements, and industry standards.

Key Responsibilities
  • Lead a global supplier quality team, providing strategic direction and guidance on quality assurance responsibilities.
  • Develop and implement quality management systems, ensuring compliance with regulatory requirements and industry standards.
  • Collaborate with cross-functional teams to ensure the qualification and management of suppliers and service providers.
  • Establish and maintain standard operating procedures, ensuring alignment with corporate quality standards and regulations.
  • Provide leadership and guidance on supplier quality performance, including tracking and reporting on supplier complaints, corrective actions, and non-conformances.
  • Participate in corporate-wide and department-specific meetings, representing Supplier Quality Assurance.
  • Collaborate with manufacturing and supplier teams to ensure the achievement of existing quality levels and identify opportunities for improvement.
  • Develop and maintain a plan for the professional development, coaching, and performance management of direct reports.
  • Advise and participate in IT solutions for quality system improvements.
  • Manage the implementation of policies and procedures to drive supplier quality improvement processes.
  • Manage established supplier reporting systems and prepare supplier performance metrics and risk determination.
  • Develop and maintain supplier quality agreements.
  • Coordinate the scheduling of supplier audits and serve as an audit team member, as required.
  • Lead the management and evaluation program for supplier change notifications and complaint/corrective actions.
  • Represent Supplier Quality function during internal and external audits and management reviews.
  • Manage the resolution of supplier-related quality problems, including internal failures, customer complaints, and audit findings.
Qualifications

The ideal candidate will possess a Bachelor's Degree in Engineering or a related field and have a minimum of 10 years of experience in the medical device/pharma industry. They will also have experience managing and developing staff, as well as experience with quality systems in a global shared service model.

The candidate should have advanced level experience using MasterControl, Compliance Wire, and/or other LMS and eQMS software, as well as strong knowledge of medical device supplier quality management and regulatory requirements.

They should also be proficient in PPAP, CAPA, Auditing, and Quality Agreements, and have a thorough knowledge of applicable regulations, such as ISO 13485:2016 and 21 CFR 820.

As an employee of CooperSurgical, the candidate will receive an outstanding total compensation package, including medical coverage, 401(k), parental leave, fertility benefits, paid time off, and multiple other perks and benefits.

CooperSurgical is committed to equal employment opportunity and is proud to be an equal opportunity workplace.

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