Senior R&D Quality Engineer

D&K Engineering Pte Ltd  

Job Description

These may include, but are not limited to:

  • Champion the development and maintenance of ISO9000 and ISO13485 Quality Management System (QMS) for the R&D department
  • Develop Product Quality Plan, documents and systems in conjunction with product development teams
  • Interface with regulatory agencies and actively manage Design Controls and Design History files.
  • Review and approve design verification and validation documentation
  • Drive risk assessments and FMEAs for medical and non-medical products
  • Assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements
  • Work with R&D engineers to develop the test qualification plans and execute them

 

Job Requirements:

  • Bachelor/Master degree in Electrical/Electronics, Mechanical, Quality Engineering or equivalent. ASQ certification preferred
  • Minimum 5 years of working experience in Quality, R&D or similar product development environment in the medical industry
  • Good knowledge of medical risk management practices and ISO14971
  • Experience in implementation of Quality Management System, medical product development (Class I/II/III) and design controls based on ISO9000, ISO13485, 21 CFR Part 820.
  • Good interpersonal skills, work well with other team members in a collaborative environment

 

Interested candidates, please email your resume to gary.kuik@dkengineering.com

We regret that only short-listed candidates with be notified.

 

 


  • Permanent / Full Time
  • $4000 - $5600
D&K Engineering Pte Ltd  
More from this company
Receptionist & Admin. Assistant

D&K Engineering Pte Ltd

This position is to manage the day-to-day HR Admin operations independently. The role includes providing administrative clerical support to ensure...

More Info
Senior R&D EE Engineer

D&K Engineering Pte Ltd

The responsibilities include but are not limited to: Work within a broader product development team to: Participate in ideation, conceptualization,...

More Info
Senior R&D ME Engineer

D&K Engineering Pte Ltd

The responsibilities include but are not limited to: Work within a broader product development team to: Participate in ideation, conceptualization,...

More Info
Senior R&D Firmware Engineer

D&K Engineering Pte Ltd

Work within a broader product development team to: Participate in ideation, conceptualization, design, and validation. Participate in design reviews to...

More Info