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Quality Assurance Engineer

Evolve Selection Ltd
Job LocationManchester
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Are you seeking a new and exciting position with a rapidly expanding Healthcare organisation, whose culture encourages career development and progressionOur client is in search of a motivated Quality Assurance Engineer to lead the Design Assurance activities in collaboration with cross-functional personnel.This is a full time, remote based position with occasional travel to head office in North West England when required.Ideal Requirement

  • Minimum of 3 years quality/regulatory experience or relevant design/manufacturing engineering experience.
  • Experience in product and process development.
  • Experience working in a regulated environment.
  • Ideally a minimum of 5 years quality/regulatory experience.
  • ISO 13485 or FDA regulated medical device experience is desired.
  • IEC62304 Software Lifecycle experience is desired.
  • Ideally experience working with complex electro-mechanical systems.
Role Responsibilities
  • Participate in core team meetings and design reviews to serve as Primary Representative of Quality and Regulatory on the product development teams.
  • Review and approve all design verification and validation protocols, plans, and records.
  • Ensure that design outputs meet the design inputs.
  • Drive risk management file activities and updates.
  • Lead the Defect Review Board for assigned products and verify acceptable resolution of design defects.
  • Assist in the establishment of quality acceptance criteria and activities including but not limited to incoming, in-process and final inspection for new products.
  • Ensure production equivalency is reviewed, documented, and tracked as required per verification and validation protocols.
  • Participate in change control activities to ensure the Device Master Record (DMR) is maintained.
  • Ensure compliance to internal QMS documentation and ISO 9001 or ISO 13485.
  • Establish quality metrics for design control conformance to demonstrate the level of effectiveness of the process.
Role Specific Competencies
  • Ability to make decisions and execute directives.
  • Strongly demonstrated attention to detail.
  • Self-starter, organised, analytical and decisive.
  • Team oriented with strong communication skills.
Recruitment Process2/3 stage process.Interested Please click apply, or contact Claire Handley to discuss further!Evolve is a leading recruitment and outsourcing organisation, operating within the Pharmaceutical, Healthcare, Medical Device and Life Science sectors.

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