Manager of Quality Assurance
- $80,000 to $100,000 Yearly
- Vision , Medical , Dental , Paid Time Off , Retirement
- Full-Time
Job Title: Manager of Quality Assurance
Industry: Biotechnology
Functional Area: Quality Assurance
Minimum Requirements:
- 5-8 Years of Quality Assurance Management Experience
- Bachelors Degree
- ISO 13485 experience required
- Proficiency in conducting QMS audits within a regulated setting.
- Skilled in drafting standard operating procedures, quality assurance protocols, work instructions, and documentation
- Comprehensive understanding of legal and regulatory standards at all levels
Role Summary:
As the Quality Assurance Manager, you will be instrumental in maintaining our commitment to quality and compliance. This includes adherence to regulations set by the FDA, ISO, ASTM, and the European Medical Device Regulation. Your role will be central to the continual development and improvement of our QMS, aligning with both our operational objectives and the evolving landscape of industry regulations.
Primary Responsibilities:
- Regulatory Compliance: Ensure all products, processes, and services comply with necessary regulatory standards, including but not limited to the FDA, ISO, ASTM, and European Medical Device Regulation.
- QMS Leadership: Drive the development, implementation, and ongoing refinement of our Quality Management System, ensuring it remains effective and responsive to changes in operations and regulations.
- Proactive Quality Management: Lead efforts in product conformity assessments and the execution of corrective actions stemming from QMS audits, aiming for zero repeat non-conformances.
Benefits:
- Health Insurance (medical, dental, vision)
- 401K with match
- PTO, Paid Holidays
- Bonuses
- ST & LT Disability
- Pet-friendly
Address
Hydro Recruiting
Town of Tyngsborough, MAIndustry
Technology
Get fresh Manager of Quality Assurance jobs daily straight to your inbox!
You Already Have an Account
We're sending an email you can use to verify and access your account.
If you know your password, you can go to the sign in page.