Watertown, United States
3 months ago
- Maintaining compliance status of the company with respect to quality system certifications to ISO 13485:2016.
- Maintaining and enhancing processes to ensure quality system compliance with the FDA Quality System Regulation.
- Will be the ISO Management Representative and MDR Person.
- Oversees the scheduling, performance and responses to internal and external audits.
- Manages the company CAPA system.
- Leading Management Review meetings.
- Overseeing, maintaining, and creating Quality System documentation and regulatory files.
- Reviewing and approving validation activities.
- Leading Incoming Inspection, Document Control and Supplier Quality functions.
Qualifications / Experience Requirements
- Minimum of 5 years as a manager of QA/RA at a medical manufacturing company.
- Working knowledge of FDA Quality Systems Regulation and other countries may be necessary.
- Experience with specific devices containing hardware and software components.
- Excellent communication, interpersonal, time management, and leadership skills.
- We require someone willing to roll up their sleeves to get things done and not merely to pontificate and/or to direct the actions of others.
- Bachelor's Degree in Engineering.