
Senior Quality Assurance Manager
1 day ago
At TN Sweden, our purpose is to create advanced assistive solutions that make a difference in the lives of adults and children living with disabilities. Our people are passionate about pushing the boundaries of technology to deliver innovations that improve lives.
Position Overview
We are now looking for a Site Quality Manager who will lead the site QA team and qualify as the Person Responsible for Regulatory Compliance (PRRC). In this role, you will develop and manage the local QA team, support the organization to continuously improve quality, and ensure compliance with regulatory requirements.
Key Responsibilities:
- Lead site Quality Team
- PRRC (where the site is the legal manufacturer)
- QA support for site functions including Operation, Production, Supply Chain, R&D
- Ensure assigned QMS processes are compliant with applicable regulatory requirements for medical devices
- Review the implementation and efficiency of QMS processes within the organization
- Function as process responsible / process owner for assigned QMS processes
- Support quality reporting, KPI collection and assessment
- Host and coordinate audits/inspections
- Act as internal auditor
Requirements:
- Master's degree or Bachelor's degree preferably in science and engineering
- Good knowledge of quality systems, quality assurance, and regulatory standards within the Medical Device or Pharma industry
- At least 5 years of working experience in a similar role
- Able to be PRRC for products where the site is the legal manufacturer
- Previous experience ensuring QMS processes are compliant with applicable regulatory requirements for medical devices
- Good knowledge of risk management
- Fluent in English and Swedish both oral and written
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