Quality Engineer

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 Med Tech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission to deliver best-in-class global Med Tech 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.

• Management of equipment procurement process and aids in identifying/developing criteria for procurement/installation of new Measurement and Test Equipment (M&TE) for laboratories.
• Designs and executes 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.
• Assist with completion of equipment procurement documentation (e.g., equipment procurement form, requirement specification, etc.).
• Work with IT to ensure equipment that generates electronic data is complaint with 21 CFR Part 11.
• Investigates and troubleshoots equipment issues and assists with nonconformance, corrective action and preventative action documentation where appropriate.
• Write and implements change control plans and risk assessments.
• Experienced with coordinating and documenting 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 where appropriate.
• Trend equipment calibration and performance failures.
• Maintains 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 Info Center software.
• Documentation of Equipment Service through Service Request Records.
• Obtain quotes and completes 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.
• Assist departments with ensuring lab equipment is compliant to appropriate standards/ranges/tolerances.
• Perform engineering and/or metrology assignments involving equipment or product design.
• Assist with training of 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.

• Bachelor 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.
• Written and verbal communication skills.
• Strong organizational and time management skills.
• Able to excel both as part of a team and independently.

• The physical demands described here 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 the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and climb or balance.
• The employee must frequently lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision,…