Principal Quality Engineer (Finance)
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.
Job Description:
• Champions initiatives for identifying/developing criteria for procurement/installation of new Measurement and Test Equipment (M&TE) for laboratories with respect to testing standards.
• Responsible for design, writing, and executing non-routine qualifications, requalifications, process validations, and building validations for M&TE as required by appropriate industry regulations and standards (e.g., 21 CFR Part 820, ISO 17025).
• Analyze qualification, requalification and validation raw data and generate final reports.
• Collaborates with CSV and IT to complete GxP documentation, compliance, and validation of equipment that generates electronic data compliant with industry regulations and standards (e.g. 21 CFR Part 11).
• Investigate and troubleshoots using advanced mathematical and engineering knowledge.
• Write/implement quality records such as change control plans, risk assessments, nonconformance, corrective action and preventative action.
• Expertly applies technical aptitude for requalifying, conducting process validations and trouble-shooting sterilizers and resistometers.
• Experienced driving purchasing process for materials/services needed for owning departments.
• Maintain and support equipment documentation in the Equipment Management System.
• Collaborates with departments to provide training to Associates for equipment use and processes.
• Drive proactive solutions when trending and analysis of TE failures observed.
• Expert installing, validating, troubleshooting, and maintaining continual monitoring points.
• Assists laboratory personnel with continuous monitoring and alarm investigations.
• Completes periodic review of Engineering owned software systems.
• Assists Engineering Management with additional department metrics/data gathering utilized in management review/support capital projects.
• Provide equipment records to appropriate staff as needed for client audits and dedicated qualification/validation SME where appropriate.
• Aligns with Engineering Management by mentoring teammates, prioritizing team tasks, and providing guidance.
• Apply standard engineering techniques to assist laboratories with proactive equipment planning.
• Ensure electronic and paper equipment files are retired/archived and when appropriate, disposed appropriately.
• Interfaces with groups within the organization on equipment and quality-related issues.
• Assists updating procedures and training related to local and global engineering processes.
• Assist Engineering Management with harmonization of equipment, equipment processes and documentation to other NAMSA sites ensure global alignment.
• Assist Engineering Management with internal/external document review for revised industry regulations and standards
Qualifications & Technical Competencies:
• Bachelor's degree in engineering or related scientific discipline required, M.S. preferred.
• 8 to 10 years of related work experience in Engineering.
• Microsoft Word, Excel, and Project experience required.
• Expertly applies regulatory requirements to requirement specifications, system qualifications, validations, protocols, equipment operating procedures, standard operating procedures, and validation reports.
• Technical expert of Building Automation System.
• Strong written/verbal communication, organization, and time management skills.
• Able to excel both as part of a team and independently, with a focus on mentoring Engineering Associates.
• Demonstrates critical thinking skills to identify, design, configure, and complete validation process for Engineering software systems.
• Strong project management skills ensuring timely completion, within budget, coordinating with departments and vendors as needed.
Working Conditions:
• 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, depth perception, and ability to adjust focus.
