Quality Engineer

About Us

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 began regulating such products in 1976. We shape the industry by developing the test methods that govern it and have become its premier provider. We support clients during every step of the product development lifecycle and beyond.

Our vision is to inspire innovative MedTech solutions that advance global healthcare, improve patient lives, and accelerate client success. Our mission is to deliver best-in-class global MedTech development solutions through our people, expertise, and technology, adhering to core values: acting with integrity, providing best-in-class customer experiences, developing superior talent, responding with agility, and embracing collaboration and diverse perspectives.

Responsibilities

• Manage the equipment procurement process and aid in identifying/developing criteria for procurement and installation of new Measurement and Test Equipment (M&TE) for laboratories.
• Design and execute qualifications, requalifications, and process validations of M&TE as required by Biotech and Pharmaceutical industry regulations and standards (e.g., 21 CFR Part 820, ISO 17025).
• Analyze qualification, requalification, and validation raw data and generate final reports.
• Assist with completion of equipment procurement documentation (e.g., equipment procurement form, requirement specification).
• Work with IT to ensure equipment generating electronic data complies with 21 CFR Part 11.
• Investigate and troubleshoot equipment issues and assist with nonconformance, corrective action, and preventative action documentation.
• Write and implement change control plans and risk assessments.
• Coordinate and document scheduled and unscheduled maintenance to maintain qualified laboratory equipment.
• Apply engineering practices to ensure equipment is properly installed, maintained, and labeled.
• Perform raw data review for qualifications, calibrations, and equipment service.
• Provide training on equipment use to laboratory and support staff.
• Trend equipment calibration and performance failures.
• Maintain equipment specification and qualification data in the Equipment Management System.
• Install, qualify, and maintain Siemens monitoring points for continual monitoring.
• Support maintenance and upgrades of Insight and InfoCenter software.
• Document equipment service through Service Request Records.
• Obtain quotes and complete requisitions for outside service on behalf of owning departments.
• Purchase materials needed to complete equipment qualifications.
• Assist laboratory staff with assessment of equipment capabilities with respect to testing standards.
• Provide equipment records to appropriate staff as needed for client audits.
• Assist equipment owners and facilities staff with autoclave issue troubleshooting.
• Assist with writing, coordination, and implementation of change control plans.
• Ensure lab equipment complies with appropriate standards, ranges, and tolerances.
• Perform engineering and/or metrology assignments involving equipment or product design.
• Assist with training associates on new and existing equipment and processes.
• Apply standard engineering techniques to improve various processes.
• Prepare written technical documents such as protocols, final reports, SOPs, EOPs, and MNTs.

Requirements

• Bachelor’s degree in engineering or related scientific discipline + 2-3 years of related work experience; or Associate degree with at least 5 years of related work experience.
• Microsoft Word and Excel experience required.
• Knowledge of regulatory requirements, requirement specifications, systems qualifications and protocols, equipment operating procedures, standard operating procedures, and validation reports.
• Strong written and verbal communication skills.
• Strong organizational and time management skills.
• Able to excel both as part of a team and independently.

Pay

Compensation target: $90,000.00 annually. Salary range: $70,000–$95,000 USD. The compensation grade range for this position is $56,000.00–$109,000.00 annually. Individual base pay depends on factors such as complexity and responsibility of the role, job duties, relevant experience, and skills.

Working Conditions

The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Regularly required to talk or hear.
• Frequently required to stand, walk, sit, use hands to finger, handle, or feel, reach with hands and arms, and climb or balance.
• Must frequently lift and/or move up to 50 pounds.
• Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.