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Quality Assurance Specialist
2 weeks ago
We are seeking an experienced Quality Engineer to join our team. This individual will play a critical role in ensuring the highest standards of quality and compliance across medical device manufacturing operations.
Key ResponsibilitiesThe successful candidate will be responsible for partnering with manufacturing process owners to identify and remediate compliance gaps, supporting manufacturing process validation activities (IQ/OQ/PQ), updating quality system documentation and technical files to ensure audit readiness, driving closure of CAPAs and NCRs with effective corrective actions, providing clear and concise technical writing for quality and manufacturing procedures, and collaborating cross-functionally with Quality, Manufacturing, and Regulatory teams to implement compliant solutions.
Qualifications & ExperienceWe are looking for a highly skilled Quality Engineer with a Bachelor's degree in Engineering or a Quality-related discipline, 25 years of experience in medical device manufacturing, quality, or remediation projects, strong knowledge of process validation (IQ/OQ/PQ) and CAPA/NCR management, proven technical writing and documentation skills, familiarity with 21 CFR Part 820 and ISO 13485 quality standards, and excellent problem-solving skills with the ability to take a problem statement through to a compliant solution.
BenefitsThis is a fantastic opportunity to work directly onsite and drive compliance improvements and process validation initiatives.
