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Intertwined

Sr. Quality Engineer

Full Time
Alburtis, PA, USA
Description

The Denzel Group, an award-winning search firm, has been chosen to work with a Global Medical Device leader on their quest for a few talented Sr. Quality Engineer. If you’re seeking a fast-paced, highly collaborative environment with the career advancing power of a global industry leader, this is the role for you!


Responsibilities

  • Participate in investigations and quality engineering.

  • Establish quality standards for products and processes.

  • Suggest modifications to prevent defects.

  • Work with cross functional teams, including product design, management and production, to identify and mitigate quality risks.

  • Audit logistics processes.

  • Support non-conformance with root cause analysis, investigations, CAPAs, risk management, FMEA.

  • Participate on material review board.

  • Ensure compliance with ISO 13485 and 21 CRF 820


Requirements
  • 7+ years’ Quality Engineering in GMP Med Device or Pharma environments. 

  • Experience with aspects such as investigations, CAPAs, risk management, statistical process control, design of experiments, failure mode and effects analysis, root cause analysis, etc.


To apply please send your application to mschroeder@thedenzelgroup.com


#INDP


QE, quality engineer, investigation, capa, risk, root cause, FMEA, DOE, design of experiments, SPC, statistical process control, APQP, advanced product quality planning, MRB, material review, medical device, ISO 13485, 21 crf 820

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