Quality Assurance Compliance Specialist

Quality Engineer / Quality Compliance Engineer

• Will provide cross-divisional support for remediation efforts. Under broad supervision, responsible for independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products.
• Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR’s, product specifications, design control files, and CE technical files.

• 2–5 years of Quality Engineering experience
• Medical device or pharmaceutical industry experience required
• Strong working knowledge of 21 CFR Part 820 and/or ISO 13485
• Hands‑on experience with Device History Files (DHF) and CAPA
• Experience supporting operations, investigations, and compliance activities in a regulated environment

• Bachelor’s degree in Engineering, Science, Math or other related technical field.

• Provide Quality expertise in Product Development, QMS, Design Control activities, Design History Files, CAPA, Risk Management, and CE Technical Files.
• Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs.
• Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
• Ensure compliance with domestic and international regulations associated with product lines and processes.
• Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.
• Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
• Design experiments to understand sources of variation affecting products and processes.
• Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
• Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates.
• Generate and analyze reports and defective products to determine trends and lead corrective actions.
• Use concepts of probability and statistical quality control to guide decisions.
• Coordinate product testing with internal and external laboratories as required.
• Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations.
• Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required.