Quality Assurance Associate ensuring product quality from raw materials to finished goods at RUF. Conducting quality checks and supervising production processes in the food industry.
About the role
- Sr. Quality Engineer leading design control activities across Veracyte’s IVD product lifecycle. Ensuring compliance with regulatory requirements in a hybrid work environment across the United States.
Responsibilities
- Lead the design control activities across Veracyte’s IVD product lifecycle.
- Ensure compliance with ISO 13485, IVDR, FDA QSR, ISO 14971 and other global regulatory requirements.
- Serve as the primary Quality partner to R&D and cross-functional teams.
- Drive robust design control execution, effective risk management, and sustained audit readiness.
- Participate in internal and external audits, serving as the SME for design control and risk management.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field.
- 7+ years of experience in Quality Assurance or Quality Engineering in the medical device or IVD industry.
- In‑depth working knowledge of in‑vitro diagnostic device quality requirements, including ISO 13485:2016, IVDR (EU 2017/746) and ISO 14971:2019 risk management.
- Hands-on experience with risk management per ISO 14971, design history files, verification & validation, CAPA, and change control.
- Strong problem-solving and organizational skills.
Benefits
- competitive compensation and benefits
- significant career opportunities
- employee engagement programs
- inclusive workforce environment
- flexible work arrangements
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