Quality Assurance Specialist
23 hours ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Kerecis LLC. The successful candidate will be responsible for ensuring the quality and compliance of our medical devices, while working closely with cross-functional teams to drive quality initiatives and improve processes.
Key Responsibilities- Develop and maintain quality systems and processes to ensure compliance with regulatory requirements
- Conduct audits and inspections to identify areas for improvement and implement corrective actions
- Collaborate with product development teams to ensure quality and compliance throughout the product lifecycle
- Investigate and resolve customer complaints and product returns
- Develop and maintain training programs for quality-related topics
- Stay up-to-date with regulatory requirements and industry standards
- BS in Engineering or Technical Field, advanced degree preferred
- 5+ years of medical device experience
- Strong knowledge of FDA, cGMP, ISO 13485, and ISO 14971
- Excellent communication and problem-solving skills
- Ability to work in a fast-paced environment and prioritize multiple tasks
Kerecis LLC offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.
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