Quality Assurance Manager

4 weeks ago


Denver, Colorado, United States CONMED Corporation Full time
Job Title: Quality Assurance Manager

CONMED Corporation is seeking a highly skilled Quality Assurance Manager to join our team. The successful candidate will be responsible for ensuring compliance to FDA Quality System Regulations and ISO13485 standards for all quality system processes and procedures.

Key Responsibilities:
  • Manage the implementation and maintenance of quality system processes and procedures to ensure compliance with FDA QSR and ISO13485 requirements.
  • Consult with Manufacturing and R&D teams to ensure proper use and understanding of quality tools and processes.
  • Ensure that all manufacturing processes and products are in full compliance with all regulatory requirements.
  • Manage the CAPA process to ensure effective root cause corrective action is implemented to address nonconformance.
  • Direct the Quality Assurance departmental budget and ensure a high level of fiscal responsibility within the organization.
  • Provide adequate budget to ensure Quality Engineering and Assurance groups are adequately trained and requirements are met to service the business.
  • Supervise personnel in the Quality Assurance group in a fair and consistent manner.
  • Act as backup Quality Management Representative for the specified R&D facility.
  • Host and be responsible for all government inspections and QS Audits.
Requirements:
  • Bachelor's degree in Engineering or related discipline.
  • Minimum 8 years' experience in Manufacturing/Quality Assurance environments and with at least 3-4 years in Medical Device or other FDA regulated industries.
  • Proficient in Microsoft Office Suite.
  • Strong working knowledge of QSR/ISO requirements.
  • Strong working knowledge of quality assurance and manufacturing principles and practices.
  • Ability to sit/stand for 8 hours.
Preferred Qualifications:
  • Master's degree or MBA preferred.
  • Quality Certifications (CQM, CQE, CQA, or Lead Assessor) desirable.

CONMED Corporation is an Equal Opportunity Employer and an Affirmative Action Employer. We are a strong advocate of workforce diversity and are committed to providing a fair and inclusive work environment. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, citizenship status, or veteran status.



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