SENIOR QUALITY ENGINEER-MED DEVICE

Location: CARLSBAD, CA
Date Posted: 07-12-2018
We are pleased to present the following job opportunity with our client!  Take a look and if you meet the requirements please submit your resume and we'll be in touch if you're a good fit!
 
 
This position supports and guides a product development and sustain teams through the design life cycle, including the design transfer of the product into manufacturing, and incurring post market surveillance monitoring ensuring compliance with the Quality System Regulations, 21 CFR Part 820, and ISO 13485.  An associate in this position is viewed as an active and valued contributor to the design, risk analysis, project plan, process validation, and design transfer.   The associate would be required to balance business objectives and quality requirements to determine readiness of projects to proceed to the next phase.   Their background in risk management would enable them to conduct safety, efficacy and hazard analysis [SHA], and failure modes and effects analysis [FMEA].  
 
You are responsible for:
 
  • Perform technical reviews and/or develop key documents including quality and reliability plans, FMECA, design reviews, design verification and validation plans/reports, product and process validation, pilot runs and sample size justification.
  • Approve Change Request end ensure their accuracy and adequacy
  • Develop inspection criteria for components and finished devices.
  • Perform and/or coordinate supplier audits as it pertains to R&D supplier selection process.  Including supplier part and process qualifications and validations.
  • Provide input to budget, planning, and evaluation processes.
  • Assist the Research and Development department to verify that; modifications to the manufacturing processes and/or product design do not affect product suitability for its intended use; assist in IQ, OQ, PQ of new equipment and processes.
 
BEHAVIORS: The successful candidate will demonstrate:
 
  • Eagerness to Win
  • Take an outside perspective, serve our customers
  • Ensure speed of action and outpace competition
  • Ability to Take Ownership
  • Take Courageous Decisions
  • Has the ability to identify and solve a problem.
  • Focus on results over activity
  • Be Goal Oriented: Demonstrates high level ambition and positive attitude about long term prospects for successfully addressing new and demanding challenges.
  • Execute rigorously, see things through
  • Be Detail Mindedness: Apply the informed attention to facts and experiences that make one a highly competent, skilled expert
  • Ability to Team up and Excel
  • Have open and tough dialogues, productive conclusions
  • Collaborate
  • Learn, Improve, and Develop
  • Demonstrate Learning Agility: Aggressively learning and applying new skills/knowledge required to be successful within new, changing or uncertain conditions.
 
 
EDUCATION:
 
  • B.S. degree in an engineering discipline, Electrical Engineer degree or a related technical field or equivalent is highly desirable. ASQ (CQE, CRE, CQA) Certifications a plus.
 
 
EXPERIENCE:
 
3+ years of experience as a Quality/Reliability Engineer, Design Engineer working within the framework of a Quality System. Experience with medical device manufacturing with electronic and/or electromechanical products preferred.
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
"Bringing Talent to the Marketplace"

KP Recruiting Group is a well established and very respected recruiting firm.  We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients.  We are very experienced in many industries and have a wide range of clients.  We will serve as your advocate during your career search!  Let us do the work for you!  There is never a fee for our services!



 
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