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Vacancy Details

Engineering & Technical

Senior Design Assurance Engineer - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 21/05/2018
Job Reference: 93459

Job Description

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

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

Job Purpose
  • Fulfil the quality assurance responsibilities of company’s product development and related sustaining engineering activities, including:
  • Creating and maintaining a culture of commitment to improving patient safety, customer satisfaction and product quality in the company.
  • Assuring compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry.
  • Promoting and effecting compliance to the company’s quality, business and health & safety systems and market/legal regulations.
  • Analysing, reducing and managing risks associated with the design, use and manufacture of company devices.
  • Providing expertise in the company’s product development systems to project teams
  • Supervising, leading and coaching members of the design assurance department

Key Responsibilities
General
  • Interfaces with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment.
  • Liaise with corporate and divisional quality systems and regulatory affairs personnel in ensuring compliance of product development activities to internal and external requirements.
  • Monitor the release and updates of quality policies to ensure compliance with Product Development needs and communication of this information to the Product Development Group.
  • Continually seeks to drive improvements in product and process quality.
  • Implement, maintain and update procedures that ensure that R&D documentation constantly meets company Product Development Process and Design Control requirements.
  • Provides the quality/independent review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.

Technical
  • Provides regulatory compliance, risk management, design control and quality systems expertise to the team.
  • Identifies and resolves complex exceptions to work assignments.
  • Summarises, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
  • Fully conversant with verification/validation techniques, risk management, statistical techniques and associated regulatory requirements
  • Build Quality into all aspects of work by maintaining compliance to all quality requirements.
  • Keeps up to date on all ISO/EN/FDA/MDD and other Product Development related regulatory requirements and relay this information to the Product Development group.
Leadership
  • Is an active member of the project team, formulating strategy and leading execution on quality deliverables as outlined in the company’s Product Development Process (PDP), Recertification, Risk Management and Design Control SOPs.
  • Co-ordination of team activities in line with departmental objectives and project goals.
  • Supervision and development of staff reporting to them in line with departmental and project goals.
  • Uses opportunities in project assignments to develop other team members.
  • Coaches others in analysis and decision making. A source of technical guidance to Quality Engineer II, Quality Engineer I, Graduate Quality Engineer, Technician and Inspection staff.
  • Is perceived as a proponent of change within the project/department and willing to challenge the status quo to create best in class.
  • Is a good team member, committed to the project’s success and fully motivated to achieve and demonstrate best practices in line with the department and site objectives.
  • Provide guidance on design control requirements to PDP/TDP teams and sustaining engineering activities in line with company policies and procedures

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 Senior 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
Please Note: HERO Recruitment will not forward your details to any company without your prior approval


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“Merit Medical have partnered with Hero for the past 10 years. During this time we have grown our employee numbers to 630 employees. Our experience of working with HERO is that they have a personal client focused approach, they know the market and they can deliver on the candidates.  The medical device market is competitive and our company success is dependent on the quality of our people, we want the best there is in the market so we can grow and in turn offer development opportunities to our people. 

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