Calibration 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:

• \tApply measurement science, mathematics, physics and engineering to design and develop methods for calibrating Measurement and Test Equipment (M&TE).
• \tExpert of Measurement and Test Equipment (M&TE) and ensures they are maintained as required by appropriate Biotech and Pharmaceutical industry regulations and standards (e.g., 21 CFR Part 820, ISO 17025, etc.).
• \tAnalyze and troubleshoot issues using advanced mathematical and engineering knowledge.
• \tUtilize statistics to analyze measurement standards and processes.
• \tTrend performance and failures for M&TE.
• \tAssist with maintaining the EMS and conducts administrative maintenance functions.
• \tPerform data review for qualifications, calibrations and equipment service.
• \tPrepare, review and maintain written technical documents for M&TE, including protocols, reports, Standard Operating Procedures (SOPs) and Equipment Operating Procedures (EOPs).
• \tDirect laboratory personnel in design, evaluation and calibration of instruments and test systems to ensure selection of appropriate laboratory equipment based on testing requirements.
• \tExecutes equipment procurement process and assists laboratory personnel in identifying/developing criteria for procurement/installation of new M&TE. Ensures that new M&TE are properly calibrated and/or qualified prior to laboratory use.
• \tAssist with identification and assessment of M&TE that generates electronic data to ensure compliance with 21 CFR Part 11. Maintain 21 CFR Part 11 assessment information within the EMS.
• \tAssist Laboratory Associates with quality documentation (e.g., nonconformances, corrective actions, risk assessments, etc.) for M&TE.
• \tResponsible for the installation, point validation and maintenance of continual monitoring points.
• \tAssist laboratory personnel with continuous monitoring and alarm investigations and provide reports.
• \tCoordinate, maintain and review scheduled and unscheduled maintenance performed for M&TE.
• \tWorks with Laboratory Staff and outside service suppliers to maintain M&TE.
• \tAssesses and documents impacts to M&TE caused by equipment service, changes or other issues.
• \tSubmit requisitions on behalf of laboratory personnel for outside contracted services and materials needed to complete equipment qualifications or repairs.
• \tTrain Laboratory Associates on proper equipment use and related NAMSA SOPs.
• \tSupport audit requests for information related to M&TE, the EMS and related processes.
• \tApply standard Engineering techniques to identify and implement process improvements.
• \tOther duties as assigned by Engineering Management.

Qualifications & Technical Competencies:

• Bachelor's degree in Engineering or related scientific discipline required.
• 1 to 2 years of related work experience.
• Microsoft Word and Excel experience required.
Technical Competencies
• 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.

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.