Quality Assurance Manager
5 days ago
We are looking for a highly skilled Quality Assurance Manager to join our team in Uppsala, Sweden.
About the Role:The ideal candidate will have extensive experience in quality assurance, with a strong understanding of industry best practices and regulatory requirements.
Key Responsibilities:- Develop and implement quality assurance processes to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to drive continuous improvements in the quality assurance process.
- Provide expertise and support during audits, inspections, or inquiries from regulatory authorities.
- Identify, assess, and mitigate risks associated with medical device development.
- Develop and update quality assurance documentation, including quality manuals, procedures, and records.
- Master's or Bachelor's degree in Life Sciences or related discipline.
- Several years of experience in quality assurance within the Life Science Industry.
- Fluent in English with strong written and verbal communication skills.
- Experience with GMP is required.
- Proficiency in regulations such as EU MDR 2017/745 and 21 CFR 820.30, as well as ISO 13485 Quality Management System is required.
- Desired knowledge in Risk Management ISO 14971/ISO 24971 and Usability IEC 62366 for Medical Devices.
- Advantageous to have experience in device development and leading cross-functional teams across various functions such as Pre-Clinical, CMC, Clinical, Manufacturing & Operations, Regulatory, Quality, and Commercial.
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