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Design Assurance Engineer

Job Title: Design Assurance Engineer
Contract Type: Permanent
Location: Galway
Industry:
REF: 88962
Job Published: 26 days ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 091730022

Design Assurance Engineer
Our client, a medical device company in Galway are currently looking to recruit a Design Assurance Engineer for their site.


Key Responsibilities
General
  • Completes work assignments under limited supervision/guidance.
  • Interfaces with R&D, Regulatory Affairs, Clinical Marketing, Process Development and Manufacturing in a project team environment providing technical and Quality systems input to the team.
  • Familiarity with requirements and procedures that govern the Product Development Process and Design Control requirements.
  • Identifies and resolves complex exceptions to work assignments.
  • Seeks to support improvements in product and process quality
  • Builds Quality into all aspects of work by maintaining compliance to all quality requirements. Participates in the company's internal audit program.
  • Excellent interpersonal and communication skills with good leadership abilities.
Technical
  • 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.
  • Experienced in validation techniques, risk management, statistical techniques and compliance to regulatory requirements. Responsible for the compilation of design verification/validation protocols, reports and design/quality documentation supporting product development/sustaining engineering projects.
  • Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
  • Excellent analytical and problem solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.
  • Updates Quality policies to ensure compliance with Product Development needs and relay this information to the Product Development Group.
Leadership
  • Is an active team member completing quality deliverables associated with the company's product development and sustaining engineering projects.
  • Coaches others in areas of expertise. Gives technical guidance to Design Assurance Engineer I, Graduate Design Assurance Engineer and Design Assurance Technicians.
  • Is a good team member, fully motivated to achieve and demonstrate best practices in line with the project, department and site objectives.
  • Supervision and development of staff reporting to them in line with departmental and project goals.
  • Uses opportunities in project assignments to develop self & other team members.
  • Provides guidance on design control requirements to PDP/TDP teams and sustaining engineering activities in line with Corporate and company SOP's
  • Is willing to implement changes within the project/department practices and supports a culture of challenging the status quo to create best in class.
Qualifications
  • HETCA Level 8 in a relevant area with a minimum of 5 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

For further information on this Design Assurance Engineer role in Galway please contact Bimi Felix on 091730022 / bimi@hero.ie
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