Senior Manufacturing Quality Assurance Lead
We are seeking a highly skilled and experienced Senior Manufacturing Quality Assurance Lead to oversee quality assurance across manufacturing processes and external suppliers. The ideal candidate will have a proven track record of ensuring compliance with regulatory standards, such as ISO 13485 and FDA 21 CFR Part 820.
Key Responsibilities:
* Develop and implement quality management systems to ensure adherence to regulatory requirements
* Lead root cause investigations and manage corrective actions to prevent recurrence
* Support process validations, including IQ/OQ/PQ, and documentation reviews to ensure product quality and safety
* Manage supplier performance and participate in audits to ensure compliance with regulatory standards
* Collaborate with cross-functional teams to drive continuous improvement and enhance overall quality performance
Requirements:
* Bachelor's degree in Engineering, Quality, or a related field
* At least 3-7 years of experience in QA or manufacturing in a regulated industry (preferably medical devices)
* Strong knowledge of quality management principles, including CAPA, non-conformances, and process validation
* Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams