Quality Manager I
270 Albany Street, USMA0009 Cambridge, MA
The primary role will be to manage QA elements of cGMP Quality System at the Cambridge facility.
As a member of the Cambridge Quality team, the person will work closely with Software Development personnel and the Frankfurt Quality team in support of medical device development activities.
Essential job junctions with respect to the Cambridge facility include:
- Managing the CAPA portfolio of projects to ensure these issues are being managed in a timely and compliant manner
- Ensuring the effectiveness of the CAPA program at the site
- Managing the Event portfolio to ensure Event closure in a timely and compliant manner
- Leading or supporting root cause investigations
- Managing the Cambridge Training Program
- Providing support of site audits
- Participating in the creation and updating of processes and work instructions
- Daily QA activities and related cGMP compliance
- Knowledge of FDA Regulations Part 11 and Part 820, ISO 13485, and IEC 62304
- Experience in medical device, pharmaceutical/biopharmaceutical industry or related industry/cGMP environment.
- Ability to work on strict deadlines. Ability to interface with cross-functional teams. Detail oriented.
- Working knowledge of the FDA Quality System Regulation.
- Experience leading CAPA (Corrective and Preventive Action) activities.
- Well-developed communication skills, both verbal and written.
- Understanding of software engineering and development and experience in a relevant department has software as part of a medical device is a plus.
Bachelor' s degree in engineering or technical discipline
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.