Job Detail

Location Clare
Salary Negotiable
Posted
Role Type Permanent
Contact Amanda Reynolds
email technical@hero.ie

Senior R&D Design Assurance Engineer

Senior Design Assurance Engineer (R&D)


My MNC Diagnostics Client in Co. Clare are searching for a Senior Design Assurance Engineer with five years of relevant experience in DA, risk management and internal audits. to join their team on a permanent basis

Responsibilities:

  • You will act as quality representative on Design Change Projects and Innovation DP projects
  • Review design projects at each phase of the Design Control process for compliance and ensure compliant closure of Design History Files (DHFs)
  • Review and approve Validation Protocols and final validation reports
  • Solve Complex Problems and exercises judgement on the analysis of multiple sources of information
  • Conduct Internal Audits to ensure compliance of R&D and other technical areas as appropriate
  • May act as a Risk Management Specialist
  • May act as a FMEA facilitator
  • Completion of Post Market Surveillance reports

Education & Experience:

  • Bachelor’s degree in chemistry, biochemistry, biology or other relevant technical field with a minimum of 5 years’ experience in a highly regulated (FDA desirable) healthcare or related environment OR
  • Master’s degree with a minimum of 3 years’ experience in a highly regulated (FDA desirable) healthcare or related environment with a Bachelor’s degree in chemistry, biochemistry, biology or other relevant technical field OR
  • Doctoral degree with 0-2 years’ experience in a highly regulated (FDA desirable) healthcare or related environment with a Bachelor’s degree in chemistry, biochemistry, biology or other relevant technical field
  • Desirable to have previous experience in IVDDs, Design Controls and/or Risk Management

For further information on this Senior DA Engineer role in Clare please contact Amanda Reynolds on 0860468858/ technical@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

109501

  Apply with Linkedin   Apply with Indeed
Senior R&D Design Assurance Engineer

Amanda Reynolds

Role Type Permanent
Contact Amanda Reynolds
email technical@hero.ie
mobile +353 86 046 88 58
linkedIn profile click here