Senior Quality Engineer

About the role

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas.

Responsibilities

• Experienced with management of equipment procurement process and aids in identifying/developing criteria for procurement/installation of new Measurement and Test Equipment (M&TE) for laboratories with respect to testing standards.
• Design and execute qualifications, requalifications and process validations of M&TE as required by appropriate Biotech and Pharmaceutical industry regulations and standards (e.g., 21 CFR Part 820, ISO 17025, etc.).
• Analyze qualification, requalification and validation raw data and generate final reports.
• Work with IT to ensure equipment that generates electronic data is complaint with 21 CFR Part 11.
• Investigate and troubleshoots using advanced mathematical and engineering knowledge.
• Complete nonconformance, corrective action and preventative action documentation.
• Prepare, review and maintain written technical documents for M&TE, including protocols, reports, Standard Operating Procedures (SOPs) and Equipment Operating Procedures (EOPs).
• Perform raw data review for qualifications, calibrations, and equipment service.
• Write and implements change control plans and risk assessments.