Quality Assurance Specialist

Job Summary We are seeking a dynamic and detail-oriented Quality Assurance Specialist to join our team and uphold the highest standards of product quality and safety. In this role, you will be instrumental in developing, implementing, and maintaining robust quality systems that ensure compliance with industry regulations and customer expectations. Your proactive approach will help drive continuous improvement initiatives, enhance product integrity, and foster a culture of quality excellence across manufacturing processes. This position offers an exciting opportunity to contribute to innovative projects while ensuring that our products meet stringent quality standards.

MUST HOLD A SECRET CLEARANCE

Duties Develop, review, and implement quality assurance protocols aligned with

ISO 13485

(medical device quality management), FDA regulations, HACCP (Hazard Analysis Critical Control Point), CGMP (Current Good Manufacturing Practice), and

ISO 9001

standards. Conduct comprehensive quality audits to evaluate compliance with internal policies and external regulatory requirements. Perform detailed quality inspections and control checks throughout the manufacturing process to identify deviations or defects early. Collaborate with cross-functional teams to establish and improve quality systems, ensuring seamless integration into daily operations. Lead root cause analysis investigations for non-conformances, implementing corrective and preventive actions (CAPA) to mitigate future risks. Support validation activities for new products or processes, ensuring adherence to regulatory standards. Maintain meticulous documentation of all quality assurance activities, audit reports, inspection records, and compliance reports for transparency and traceability. Experience Proven experience working within regulated manufacturing environments, preferably in industries governed by

ISO 13485, FDA

regulations, HACCP, CGMP, or

ISO 9001

standards. Demonstrated expertise in conducting quality audits, inspections, and system assessments with a focus on continuous improvement. Strong knowledge of quality control techniques, quality inspection procedures, and quality management principles. Familiarity with QA/QC tools such as statistical analysis skills and problem-solving methodologies. Experience managing or supporting projects related to quality systems implementation or upgrades is highly desirable. Excellent analytical skills combined with attention to detail to identify issues promptly and effectively. Ability to collaborate across departments while maintaining a proactive approach toward achieving compliance goals. Join us in delivering exceptional products by ensuring the highest levels of quality assurance!

Pay:

$65,000.00 - $79,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person