Quality Manager

This role is responsible for ensuring the company's quality system is and maintain compliance California FDB and US FDA QSR requirements. This position has the responsibility and authority to act independently from the rest of the organization on all matters affecting product quality and compliance. Specifically, this person may initiate action to prevent non-conformities; identify and document quality problems and initiate, recommend, provide and verify solutions to quality problems. This role may require deliverables from other departments to support FDA Quality Management System requirements; may issue Corrective/Preventive Action Requests to internal departments or suppliers as required; may initiate Supplier disqualification based on continued unsatisfactory performance. 

 Principal Responsibilities: 

• Establish and Maintain Quality Management System.
• Maintain QMS Manual and associated procedures.
• Review and interpret quality/regulatory compliance requirements and ensure that they are implemented through company policies and procedures.
• Develop regulatory compliance and quality plans and strategies in concert with affected functional areas.
• Prepare and/or review FDA and other regulatory applications and documents, including Medical Device License Applications and Medical Device Reports as required.
• Review and approve all new and changed manufacturing processes to ensure compliance with requirements of FDA and FDB.
• Provide support and guidance to biocompatibility and environmental control programs.
• Review and approve all product labeling and marketing materials to ensure compliance with regulatory requirements.
• Manage Document Change Control
• Manage supplier quality management/audit program.
• Manage internal quality audit program.
• Manage Medical Device Reporting and complaint management activities.
• Develop, implement and supervise the non-conformance (NCR) and CAPA systems.
• Initiate and Chair Material Review Board (MRB) if/as required.
• Ensure training on all released QMS procedures and quality records is current.
• Ensure calibration system for all inspection, production and R&D instruments is established and maintained. 

Education / Experience Requirements:  

• Four-year bachelor's degree required. Desired in an engineering field
• Familiar with 21 CFR 820, 21 CFR Part 11, ISO 13485 and ISO 14971.
• Experience in medical device start-ups preferred
• Minimum 6 years quality experience in FDA regulated medical devices or related industry
• Familiar with 21 CFR 820, 21 CFR Part 11, ISO 13485 and ISO 14971.
• Experience in medical device start-ups
• Experience in managing sterilization controls for a Class II or Class III sterile product (EO Preferred)
• Working knowledge of current FDA Quality Systems Regulation and equivalent international requirements for medical devices.
• Direct, recent involvement in 510k Submissions, IDE Submission, and/or CE mark filings (Desired)