Employer: Nano Strings
Senior Manager, Instrumentation Maintenance/Calibration
at NanoString (View all jobs)
Greater Seattle Area, WA
The Senior Manager, Instrumentation Maintenance/Calibration will manage the development and implementation of laboratory support activities and compliance to our ISO Quality Management System for Manufacturing, Supply Chain and R&D including but not limited to temperature monitoring, and reporting software, computerized maintenance management system, equipment performance and assessment, equipment preventive maintenance and calibration, ancillary systems, quality and troubleshooting procedures, implementation of new methods, equipment installation and operation and general use laboratory equipment. Candidate must be able to work well in a team environment or individually with minimal supervision when necessary.
Please note: This position will be responsible for equipment at our South Lake Union, Seattle and Bothell offices. For the right candidate, we're flexible about what location they will be based out of.
- Ensure effective operation of all laboratory equipment by serving as the single point of contact for all preventive maintenance, calibration, repairs, and troubleshooting equipment using the computerized calibration management systems.
- Manage equipment non-conformance issues per Quality System processes.
- Responsible for development of tracking procedures, establishment and maintenance of service contracts and warranties with laboratory equipment vendors.
Perform measurement uncertainty analysis.
- Direct and coordinate the laboratory support staff and maintain an adequate inventory of research lab glassware, consumable materials and laboratory equipment.
- Provide training support to new scientific staff in the general use and function of designated instrumentation and create and refine user protocols for general use.
- Assure compliance to our ISO-13485 Management System and our Customers’ requirements
- Act as the Subject Matter Expert for Lab Services during FDA audits.
- Review and approve new equipment requisitions and ensure the preventive maintenance and calibration guidelines are in place before use.
- May organize and participate in vendor negotiations, product and software evaluations, tutorials and assist in facility modifications.
- May troubleshoot and repair general instrumentation
Select, develop, and evaluate personnel to ensure the efficient operation of the function
- Setup and implement Key Performance Indicators.
8 to 12 years of experience in a regulated ISO lab environment OR Masters with 6-10 years of experience.
4+ years of management responsibility.
Bachelor’s degree in life sciences or equivalent years of experience.
Strong background in both ISO-9000 and FDA GMP regulations.
Experience with computerized calibration management systems, such as Blue Mountain.
Strong organizational, communication, problem-solving, and troubleshooting skills.
Knowledge and expertise of precision measurement methods and procedures for many different measurement types: Temperature, Pressure, Electrical, and Flow.
Knowledge of biology or chemistry; molecular biology
Standards applicable to in vitro diagnostics
Lean Six Sigma certification
NanoString is an Equal Employment Opportunity and Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. NanoString does not accept unsolicited agency resumes and will not pay fees to any third-party agency or company that it does not have a signed agreement with.
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Location: Seattle, WA
Application Method: Online: https://boards.greenhouse.io/nanostring/jobs/4782044002
Base Pay: DOQ