Quality Manager - TM

Quality Manager

POSITION PURPOSE This position will fill a key leadership role in building and directing all company regulatory and quality system activities as it moves forward to develop and market its products. This role will be located at the GVS TM Inc facility in Covina CA.

ESSENTIAL JOB FUNCTIONS - RESPONSIBILITY & AUTHORITY

1. Develop, implement, and lead an effective globally compliant quality management system to direct the design, production, and distribution of company products. Including the development and transfer of projects with OEM contractors and internal suppliers.
2. Direct regulatory due diligence and routine audits of internal operations and global contract suppliers to assure the required regulatory compliance.
3. Direct and lead the regulatory requirements for training personnel in a dynamic organizational environment.
4. Act as the key company contact when interfacing with regulatory authorities, notified bodies, and customer audit requests.
5. Responsibility for the release of final product.
6. Partake in Management Meetings to ensure quality and efficiency in the production environment.
7. Responsible to check daily, weekly, and Monthly KPIs, including both locally and for the Corporate Quality function.

JOB REQUIREMENTS

1. Five years of management experience in a regulatory quality systems leadership role with a focus on the Medical Device & Pharmaceutical Industry.
2. B.S. or M.S. degree in a biological or natural science (biology, microbiology, biochemistry, chemistry, etc.) preferred.
3. Experience with 21 CFR 820.00, 21 CFR 600-680, MDR 2017, 745, ISO 13485:2016, alongside other global regulatory requirements.
4. Direct experience in working with US and EU regulatory authorities, including FDA, Competent Authorities, State Licensing departments, etc.
5. Excellent working knowledge of US and EU Medical Device and Pharmaceutical regulations.
6. Demonstrated leadership and management skills to direct responsibilities in an organization with both internal and outsourced globally directed projects.
7. Demonstrated balance of strategic thinking and execution-oriented skills.
8. Excellent written and verbal communications skills.
9. Proven capability in leading a multi-skilled team.
10. Working knowledge of Sterilization Techniques including Moist Heat, Gamma, and Ethylene Oxide.

PHYSICAL REQUIREMENTS

1. Employee will be required to sit/stand for extended periods of time, operate a computer and keyboard.
2. Position will be exposed to office environment with occasional interaction in a production and/or laboratory environment.
3. Some National and International travel may be required on an infrequent basis.