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Quality Assurance Director
2 months ago
We are seeking a highly experienced Director of Quality Assurance to join our team at Sekisui Diagnostics GmbH. As a key member of our organization, you will play a critical role in ensuring the quality and integrity of our products.
Key Responsibilities- Oversee the development, implementation, and maintenance of quality assurance systems and activities.
- Generate and review documents used in good manufacturing practices.
- Monitor audits of production and quality control areas.
- Audit raw material vendors and prepare manufacturing documentation for updated filing.
- Coordinate interdepartmental activities.
- Lead investigations and resolve potential product quality issues to improve efficiency.
- Select, develop, and evaluate personnel to ensure the efficient operation of the function.
To be successful in this role, you should have:
- 10+ years of experience in the IVD (reagent and/or instrumentation) industry.
- Thorough knowledge of FDA QSR, ISO 13485, and MDSAP.
- Strong experience in Firmware, Hardware, and Software Engineering.
- Experience supporting the realization of new products through new product development, third-party manufacturers, and/or mergers and acquisitions, including oversight of Design Controls.
Sekisui Diagnostics GmbH is a leading company in in vitro diagnostics, committed to improving patient outcomes by innovating and developing highly accurate diagnostics tests, reagents, and systems. We are a solid partner for healthcare professionals, distributors, and manufacturers around the world.
CompensationWe offer competitive compensation, including an anticipated base salary of $185,000-215,000. This role may also qualify for annual incentives and/or comprehensive benefits.
Diversity CommitmentWe are an equal opportunity employer, committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics as specified in applicable laws.
