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About Northreach
Northreach is a leading player in the biopharmaceutical and laboratory technology industry, dedicated to advancing scientific progress and enhancing human health. Our focus is on developing cutting-edge instrumentation and consumables that support critical applications in fields such as blood transfusion, bioreactors, and complex medical technologies. Our products are known for their precision, reliability, and integration of advanced electronic and mechanical systems.
Job Summary
We are seeking a highly experienced Quality Assurance Manager to oversee quality control for advanced instrumentation, including blood transfusion products and bioreactors. The ideal candidate will have a strong background in manufacturing and a deep understanding of instrumentation, as well as hands-on experience with software validation and lifecycle management using agile methods.
Key Responsibilities
- Develop and implement quality control processes to ensure the highest standards of product quality.
- Lead the development of both instruments and consumable products, ensuring compliance with regulations such as ISO 13485 and GMP.
- Manage risk and ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to bring new products to market.
Requirements
- Strong background in manufacturing and a deep understanding of instrumentation.
- Hands-on experience with software validation (e.g., Gamp 5) and lifecycle management using agile methods.
- Proven leadership skills with experience in managing risk and ensuring compliance.
- Flexibility to work on-site 4-5 days a week, with some room for adjustment.
About the Role
This is a critical role in a fast-evolving field, and we are looking for a passionate and innovative individual who is ready to take on new challenges. If you have a strong background in quality assurance and a passion for innovation, we encourage you to apply.