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Program Manager, Quality Supply Chain

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Location
San Francisco, CA
Job Type
Direct Hire
Date
Jun 11, 2019
Job ID
2669645

Program Manager, Quality Supply Chain


San Francisco


Our client is an exceptional team with backgrounds in technology, healthcare, CPG and biotech, and growing rapidly to deliver on their mission. Looking to hire the world’s best scientists, engineers, designers, product managers, supply chain experts, customer service and business professionals.


ROLE AND RESPONSIBILITIES:


As the Program Manager, Quality Supply Chain, you'll work closely with multiple teams and drive the development, implementation, and maintenance of the Contract Manufacturer’s Quality Management System (QMS) and related programs.



  • Serve as the principal architect and expert on the structure, content, philosophy, and operation of the Supplier QMS.
  • Act as the primary interface to external service providers executing quality assurance and regulatory compliance activities on behalf of the company.
  • Lead and ensure the following Supplier QMS related functions/systems: Production Controls, Document and Change Control, Management Review, Internal Audit, Corrective and Preventive Action, Complaint Handling and Adverse Event Reporting, DHR Review and Product Release, Non-Conforming Product, Process and Software Validation.
  • Provide for ongoing review of Supplier QMS execution activities to ensure that all quality assurance and regulatory compliance programs meet applicable regulations and standards, this will include performing or managing periodic audits.
  • Collaborate with organizational leadership in the establishment of quality assurance and regulatory compliance objectives on an annual basis.
  • Ability to travel (domestic and international) 25-30% of the time.

PERSONAL AND PROFESSIONAL QUALIFICATIONS:



  • 3+ years of combined experience in quality assurance and regulatory compliance management in the medical device industry.
  • 3 years of program or project management experience
  • General understanding of FDA and International medical device regulations
  • Experience working with ISO 13485-certified QMS processes and procedures
  • 3+ years of experience in development, implementation, and management of quality systems within a medical device company.

 EDUCATION: Bachelor’s degree in Engineering, Technology, Science related field, or equivalent practical experience. PMP Certification and ASQ Certification preferred.