Quality Engineer, Medical Devices

Quality Engineer, Medical Devices

Specialty: , Engineering

Job Description

Kendra Palmer
Sr. Staffing Manager

Kendra joined Leddy Group with the acquisition of Staff Hunters of Portsmouth in 2016.  She brings 18 years of experience recruiting in both engineering and supply chain. As Senior Staffing Manager Kendra recruits and services companies throughout the seacoast and central NH. 

603.749.2004 | KPalmer@leddygroup.com

A medical device company is looking for a Quality Engineer to join their team! The ideal candidate is an analytical thinker with strong attention to detail and previous experience in the medical device industry. Our client is open to early career candidates as well. This is an excellent full-time, direct-hire opportunity!

Responsibilities of the Quality Engineer, Medical Devices

  • Develop, document, and implement QA procedures
  • Interpret and assess conformity to regulatory standards
  • Provide analytical investigations and develop root cause for non-conformances
  • Design and specify gauging and test equipment for quality assurance
  • Write protocols, analyze data, and generate summary reports for verifications and validations
  • Lead and participate in design control projects for new and changing medical devices
  • Interface with vendors and customers as required
  • Participate in design reviews, pFMEA, risk management reviews, validations, CAPAs, NCMRs, etc.
  • Conduct supplier evaluations, qualifications, and quality audits

Qualifications of the Quality Engineer, Medical Devices

  • BS or MS in Engineering, or scientific disciple with 5-7 years of experience in the manufacture of medical devices/disposables (Class II) for the medical device market
  • 3 years Medical Device industry experience preferred
  • Certified Quality Engineer or Quality Auditor (ASQ) preferred
  • Experience with design control, process validation, failure investigations, root cause analysis, and the application of statistics to the practice of quality assurance
  • Experience participating in FMEAs or other risk assessment activities
  • Experience with supporting FDA and certified body audits
  • Clean room experience
  • Team player with strong communication, interpersonal, and presentation skills
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, drawings, and procedure manuals
  • Strong computer, math, writing, and problem-solving skills
  • Expert understanding of GMP, quality systems, ISO 13485, and FDA QSR for medical devices; knowledge of ISO 14971 and device-related compliance standards
  • Knowledge of lean manufacturing principles

We look forward to hearing from you about this Quality Engineer role!

To apply, please email an MS Word copy of your resume to kpalmer@leddygroup.com, call 603-766-2004, or apply online at www.leddygroup.com.

Veterans and military spouses are encouraged to apply.

Quality Engineer, Medical DevicesAbout Leddy Group

We are a privately owned, regional staffing company serving northern New England since 1994. We are real people helping real people find meaningful employment through our specialties:  Accounting & Finance, Administrative & Customer Service, Engineering, HR, Industrial and Skilled Manufacturing.

Kendra Palmer
Sr. Staffing Manager

Kendra joined Leddy Group with the acquisition of Staff Hunters of Portsmouth in 2016.  She brings 18 years of experience recruiting in both engineering and supply chain. As Senior Staffing Manager Kendra recruits and services companies throughout the seacoast and central NH. 

603.749.2004 | KPalmer@leddygroup.com

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