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Design Assurance Engineer

Job Title: Design Assurance Engineer
Contract Type: Permanent
Location: Galway
Industry:
REF: 93460
Job Published: 3 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 086 8395533

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

Job Purpose:
  • Fulfil the quality assurance responsibilities of the com new product development and post market (commercial product) support, including:
  • Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality in the company.
  • Understanding and complying with the company’s quality, business, health & safety systems and market/legal regulations governing the quality systems.
  • Removing or mitigating against risks associated with the design, use and manufacture of company devices.
  • Ensuring commitment to training requirements and understanding and complying with all regulations governing their work.

Key Responsibilities:
General
  • Completes work assignments under limited supervision/guidance.
  • Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.
  • Familiarity with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
  • 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.
  • Excellent interpersonal and communication skills with good leadership abilities.

Technical
  • Provides both quality and technical input to ongoing product development and post market commercial product activities.
  • Experienced in post market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements).
  • 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.

Leadership
  • Is an active team member completing quality deliverables associated with the company’s new product development and post market (commercial product) support.
  • Coaches others in areas of expertise. Gives technical guidance to junior team members. Uses opportunities in project assignments to develop self & others.
  • Is a fully motivated team member - achieves and demonstrates best practices in line with set objectives.
  • 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
  • HETAC Level 8 in a relevant area with a minimum of 5 years’ experience in a role.
  • 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 086 8395533 / bimi@hero.ie
Check out all our open jobs on our HERO Recruitment website – www.hero.ie
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