Quality Engineer in Medical Device

Mahwah, New Jersey | Quality Assurance / Safety

Quality Engineer 

 

Some opportunities come along once in a career and when they do, you have to act.  Our client is a med device start-up involved in a novel technology that addresses an unmet clinical need and it is a group of people who have successfully introduced other new product concepts to the market through start-ups.  They have recently received clearance on their 510(k) and need to move quickly.

 

Your core skills need to include Quality and Manufacturing because this person will be hands-on which means you need to have experience with typical inspection tools, their effective application and how to develop sampling plans for their use. (e.g. Have you run a GR&R, DOE, or done FMEA’s?)

 

You will be involved with TMV, IQ/OQ/PQ, and V&V efforts including Quality Plans, inspection methods and testing protocols.  Your customers will be internal, involving equipment validations, etc. and external where you will be directly involved with vendors.  Still interested?  Read on. 

 

RESPONSIBILITIES:

  • In-depth knowledge of Inspection Methods and their application and provides appropriate documentation to demonstrate their effectiveness and ongoing reliability
  • Must have hands-on experience with classic bench top gages; e.g. micrometer, go/no-go, height gages, concentricity gages, and Comparators to name a few
  • May devise Sampling Procedures/Plans from several different data sources; reporting on results and trends
  • Ensures that Quality Plans, PFMEA’s and other procedural documents meet the needs of 21 CFR 820, ISO 13485, EU MDR and other notifying bodies
  • Contributes to internal auditing needs and plans/implements Supplier Audits
  • Works with operations to coordinate and support validation activities
  • Using foundational knowledge in inspection and manufacturing, develops and initiates methods for inspection, testing, and evaluation
  • Performs hands-on inspection of First Articles, incoming, in-process and final
  • Oversees the calibration system to ensure the accuracy of results from analytical equipment, visual and measuring instruments and verifies during supplier auditing, vendor maintenance of their systems
  • Provides for disposition of discrepant material (NCMR) including rework and data trends (CAPA)
  • Interacts with vendors as a Quality Representative, ensuring their performance results and methods meet the needs of the Company’s product

REQUIREMENTS

  1. Bachelor’s degree in Engineering, with a minimum of 3 years’ experience
  2. Experience with Med Device manufacturing including clean room manufacturing
  3. Well versed in the concepts and principles of inspection techniques and methods
  4. Experience in the use and application of GD&T
  5. Able to interpret engineering drawings and effectively communicate their manufacturability
  6. Skilled in Data Analysis and Reporting
  7. Well-informed in FDA 21CFR820 & ISO 13485:2016
  8. Is a champion for Quality and building a Culture of Quality
  9. Demonstrable experience with V&V as well as IQ/OQ/PQ implementation
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