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

Quality Engineer, Medical Devices

A medical device company is looking for a Quality Engineer to join their team! In this position, you would play a key role in the manufacture and distribution of their innovative products, managing activities related to internal and external quality and regulatory compliance. The ideal candidate is an analytical thinker with strong attention to detail and previous experience in the medical device industry. 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 appropriate regulatory standards
  • Analyze non-conforming materials and returned goods and recommend disposition and corrective actions
  • Create suitable data analysis tables and report findings based on statistical evidence and trending
  • Provide analytical investigations and develop root cause for non-conformances and deviations
  • Design and specify gauging and test equipment for quality assurance functions
  • 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
  • Complete and review documentation for accuracy
  • Collaborate with various departments to establish quality standards for new and existing products
  • Participate in design reviews, pFMEA, risk management reviews, validations, CAPAs, NCMRs, etc.
  • Conduct supplier evaluations, qualifications, and quality audits
  • Perform related duties assigned

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
  • 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
  • Must have a strong computer, math, writing, and problem-solving skills
  • Expert understanding of GMP, quality systems, ISO 13485, and FDA QSR for medical devices
  • Knowledge of standards applicable to Medical Device Safety Risk Management (ISO 14971 and device-related compliance standards)
  • Knowledge of lean manufacturing principles

If you have the required qualifications and want to be an integral part of our client’s continued success, apply now for this Quality Engineer position!

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.

Quality Engineer, Medical DevicesAbout Leddy Group

We are a privately owned, regional staffing company serving northern New England since 1994.  We put the right people in the right places through our specialties:  Accounting & Finance, Administrative & Customer Service, Engineering, HR, Industrial and Skilled Manufacturing.  We combine a consistency of values and traits with a singular standard for quality and best practices. Our goal is to exceed your expectations; our success is tied directly to your satisfaction.

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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