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Design Assurance Specialist

Job Title: Design Assurance Specialist
Contract Type: Contract
Location: International
REF: 87799
Job Published: over 1 year ago

Job Description

Design Assurance Specialist

Have you worked in Risk Management in a medical device company? My client is recruiting for a DA Engineer to join their team in Germany for a Consultancy job. This Consultant will be an SME in Risk Management.

Key Responsibilities of Design Assurance Engineer Job
  • Interfaces with R&D, Process Development and Manufacturing
  • Seeks to support improvements in product and process quality
  • Builds Quality into all aspects of work by maintaining compliance to all quality requirements. Participate in internal audit program.
  • Provides both quality and technical input to the design reviews, project development/ design change/recertification plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.
  • Responsible for the compilation of design verification/validation protocols, reports and design/quality documentation supporting product development/sustaining engineering projects. Participates in Simulated Use/Bench Testing as part of both early development projects and during execution of design verification/validation studies.
  • Provides risk management and specialist in ISO 14971 and FMEA
  • Updates Quality policies to ensure compliance with Product Development needs and relay this information to the Product Development Group.

Education, Experience and Skills
  • Level 7/ 8 Education in a relevant area with a minimum of 8 years' experience in a similar environment.
  • Good technical capabilities, communication skills, teamwork abilities and initiative.
  • Proven ability to work well as part of a team & on own with minimum supervision
  • Excellent analytical and problem solving abilities.
  • SME in Risk Management and ISO 14971

For further information on this Design Assurance Engineer role or any other Design Assurance Engineering jobs please contact Cliona O'Malley on 091730022 /
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("design" OR "designed" OR "designing" OR "designer" OR "designs" OR "drawing" OR "develop" OR "developer" OR "development" OR "graphic" OR "graphics" OR "AutoCAD" OR "cad" OR "architect" OR "architecture" OR "fashion" OR "research" OR "r&d" OR "product" OR "products" OR "production" OR "solid works" OR "solid works") AND ("assurance" OR "audit" OR "auditor" OR "internal audit" OR "risk" OR "control" OR "quality" OR "standards" OR "defects" OR "qa" OR "qc" OR "mistakes" OR "defect" OR "verify" OR "safety" OR "quality assurance") AND ("engineer" OR "beng" OR "B.Eng." OR "designer" OR "eng" OR "engineering" OR "engineers" OR "engr" OR "engineered" OR "engineer" OR "eng." OR "meng" OR "scientist" OR "technician" OR "technical") AND ("chemist") AND ("mechanical" OR "Test method" OR "transfers" OR "chemistry") AND ("Ireland")