Senior Quality Engineer (Plexus, Penang Design Center)

Senior Quality Engineer (Plexus, Penang Design Center)

Plexus Manufacturing Sdn Bhd
Malaysia
5-8 years
Not Specified

Job Description


Responsibilities:
  • Identify and document product specifications related to safety agency and regulatory requirements (UL, CE, FDA, FCC, etc.) including functional, electrical, mechanical and labeling specifications as well as mentor and lead the project team on safety agency and regulatory items.
  • Lead product Risk Analysis and mitigation development efforts to confirm the design team has accurately identified product hazards, assessed the level of risk for each hazard and applied mitigation; maintaining the Risk Analysis throughout the project to ensure that hazards are assessed as the design evolves.
  • Lead Design Failure Modes and Effects Analysis (compile and maintain the necessary supporting documentation) to ensure the success of the project.
  • Lead Product Reliability Assessments to develop requirements and protocols to verify product reliability
  • Coordinate design verification test activities through the development and maintenance of verification test plans, procedures and reports to ensure verification prototypes meet design requirements and confirm effectiveness of hazard mitigations.

Requirements:
  • Master / Bachelor Degree in Electronics or Electrical & Electronics Engineering with a minimum of 5 years’ experience.Possess expert knowledge of the FDA Quality System Regulation.
  • Possess expert knowledge of ISO13485.
  • Possess moderate knowledge of ISO14971.
  • Possess moderate knowledge of IEC/UL 60601-1 and collateral standards.
  • Possess moderate knowledge of IEC/UL 61010-1 and collateral standards.
  • Possess understanding of Risk Analysis process, Failure Modes and Effects Analysis process, Fault Tree Analysis, and Requirements and Hazard Traceability processes.
  • Possess moderate knowledge of medical software development life-cycle process and requirements.
  • Possess moderate knowledge of EU Medical Device Directive.
  • Possess moderate knowledge of EU In-Vitro Diagnostic Directive.
  • Possess knowledge of EU Active Implantable Medical Device Directive.
  • Possess knowledge of the FDA 510(k) and PMA submittal process.
  • Ability to multi-task.

Job Details

Employment Types:

Function:

IT

Since 1979, Plexus has been partnering with companies to create the products that build a better world. We are a team of over 19,000, providing global Design and Development, Supply Chain Solutions, New Product Introduction, Manufacturing, and Aftermarket Services. Plexus is an industry leader that specializes in serving customers with complex products used in demanding regulatory environments. With a culture built around innovation and customer service, Plexus’ teams create customized end-to-end solutions to assure the realization of the most intricate products. We help our customers realize their most visionary ideas, and we’re dedicated to doing our work with innovation, integrity and Customer Service Excellence. To learn more click here: www.plexus.com

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