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Product Quality Engineer - Medical Device

Company: The Richmond Group
Location: Newport News
Posted on: January 15, 2022

Job Description:

Are you a Medical Device Product Quality Engineer with experience launching new medical products? Then come on and get in on the ground floor of this exciting, rapidly growing medical device business. This company is launching several new medical products this year, and they can use your skills on their team. The TRG Manufacturing Search Division has been engaged to identify a Product Quality Engineer to join a talented team of engineers working to bring new products from design into reality. This exciting start-up business has grown over the last 5 years into a versatile business that is producing a wide variety of medical device/medical equipment products for a number of different customers. In this role,, you will play a major part in the manufacturing process from developing the IQ/OQ/PQ plans through to startup of new product lines, and long-term sustaining engineering efforts. The ideal candidate will have Class I or Class II medical device experience with working knowledge of FDA regulations for design control/design transfer. If you are an engineer who enjoys launching new medical device products, then you owe it to yourself to explore this opportunity! Background:

  • Minimum of a Bachelor's degree in Engineering or related field and 2+ years of medical devices product quality engineering experience
  • Demonstrated experience planning, developing, validating, and testing manufacturing processes to meet FDA and ISO requirements (ISO13485, FDA 21CFR, GMP/GDP, etc.)
  • Hands-on experience developing and executing IQ, OQ, and PQ plans to qualify production processes, equipment, and fixtures.
  • Excellent Project Manager with strong analytical, problem solving skills. (Root Cause Analysis, Design of Experiments (DOE) and test method validations (Gage R&R)).
  • Have previous experience in product transfer and putting new Class I or Class II medical equipment into production.
  • Strong computer skills (AutoCAD, Solidworks, Microsoft Office, etc.). If you are interested in this or future opportunities in your area, please send a Word-Formatted resume to rachaelr@richgroupusa.com and we will contact you when opportunities arise that match your geography and experience. All inquiries are kept confidential and your information will not be shared without your prior approval. All qualified applicants will receive consideration for employment without regard to the individual's race, color, sex, national origin, religion, age, disability, genetic information, status as a military veteran, or any other characteristic protected by applicable law.Job Requirements:
    • Minimum of a Bachelor's degree in Engineering or related field and 2+ years of medical devices product quality engineering experience
    • Demonstrated experience planning, developing, validating, and testing manufacturing processes to meet FDA and ISO requirements (ISO13485, FDA 21CFR, GMP/GDP, etc.)
    • Hands-on experience developing and executing IQ, OQ, and PQ plans to qualify production processes, equipment, and fixtures.
    • Excellent Project Manager with strong analytical, problem solving skills. (Root Cause Analysis, Design of Experiments (DOE) and test method validations (Gage R&R)).
    • Have previous experience in product transfer and putting new Class I or Class II medical equipment into production.
    • Strong computer skills (AutoCAD, Solidworks, Microsoft Office, etc.).

Keywords: The Richmond Group, Newport News , Product Quality Engineer - Medical Device, Healthcare , Newport News, Virginia

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