Senior Quality Engineer - Calibrations

POSITION SUMMARY:

This individual fulfilling this role will have a metrology foundation and shall be able to lead and coordinate calibration activities related to daily and future operations. This position will work closely with AtriCure engineering, manufacturing, supplier quality, to ensure that quality system activities are completed.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Provides daily Quality Engineering calibration direction for inspection and testing operations where daily activities require working with collaborative cross-functional teams. Daily tasks require the timely addressing of calibration-based issues through correction and prevention processes. Specific responsibilities:


• Responsible for the development and release of operational procedures & forms for the calibration program of current and future state of calibrations at ATRC.
  
  
  
  • Development is done through collaboration with manager, calibration technicians, and stakeholders. Typical program development would include documented gap analysis, development of overall plan, and implementation of the program.
  
  
  
  


• Current activities include:
  
  
  
  • Owning and completing timely processing of all calibration program-based NCRs, INVs, and CAPAs.
  
  
  • Routinely using data, risk analysis, cost/benefit decision-making to adjust calibration intervals.
  
  
  • Assisting Calibration Technicians in developing processes for tracking device location and usage before devices are to be calibrated.
  
  
  • Leading the GR&R studies (protocols and reports) for Receiving Materials Inspection in accordance with TMV procedures.
  
  
  • Assisting in the measurement alignment of RMI and Supplier inspection methods as it relates to GR&Rs and Calibration.
  
  
  • Acting as consultant to other functions performing GR&R or TMVs in Production and/or Product Development
  
  
  • Leading in-house calibration initiative through cross functional project management and develops in house program and procedures.
  
  
  
  


• Applies reasoning ability; supports and prioritizes projects, adapts to shifting priorities, works with little guidance from management, and resolves problems/conflicts.


• Contributes to the development and implementation of quality system processes, including regulatory requirements, as applicable.


• Assists with 3rd party, internal, and external FDA and ISO audits, as necessary.


• Performs other duties as assigned.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance


• Ability to work under fast-paced conditions.


• Ability to make decisions and use good judgment.


• Ability to prioritize various duties and multitask as required.


• Ability to successfully work with others.

• Additional duties as assigned.

BASIC QUALIFICATIONS:

• Bachelor’s degree required in Engineering or demonstrated equivalent combination of education, training and experience.


• 5 - 7 years of experience in a process, manufacturing, or quality engineering role.


• 2+ years’ experience with Calibration/Metrology programs including performing GR&Rs, ensuring NIST traceability, and performing data analysis.


• Working knowledge of ISO17025


• Able to interpret design drawings (including GD&T) and product specifications.


• Problem solving/Troubleshooting experience.


• Strong interpersonal, organizational, and communication skills.


• Computer/data entry and protocol/report writing skills.


• Experience training production associates, inspectors, or junior engineers.

PREFERRED QUALIFICATIONS:

• FDA, 13485, MDD, MDR, CMDR and JPAL knowledge


• Understanding of Lean Manufacturing tools such as value stream mapping, 6S, Kazan, etc. a plus


• Engineering/design background


• Experience with process validation, design verification/design validation

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed.


• Ability to occasionally bend and push/pull as needed.


• Ability to pass pre-employment drug screen and background check.


• Ability to travel to calibration sources as needed.