Video for this job

Collins McNicholas

Job Purpose:

Fulfil the quality assurance responsibilities of the product development and related sustaining engineering activities, including:

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


Key Responsibilities


  • 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 the 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.



  • 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.



  • Is an active member of the project team, formulating strategy and leading execution on quality deliverables as outlined in their 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 projects 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 their policies and procedures.


Qualifications and Experience:

  • HETAC Level 8 in a relevant STEM discipline with a minimum of 5 years’ experience in a similar 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.
  • Knowledge & understanding of EN ISO 5840-3 is essential.
  • Material knowledge of nitinol and any experience with testing of nitinol is desirable.
  • Material knowledge of animal origin (bovine or porcine) is desirable.
  • Basic knowledge/understanding of valve testing/kinematics.
  • Basic knowledge of Finite Element Analysis.


First Name


Your Email (required)

Your mobile (required)

Preferred Collins McNicholas Office (required)

Comment / Cover Letter

Upload CV

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Med Tech Report

A new report shows that Ireland’s medical technology sector employs over 32,000 people, hosts 18 of the 25 largest Med Tech companies in the world, and has €12.6 billion worth of exports annually, making Ireland the fifth largest exporter in Europe. Ireland develops some of the most sophisticated products in the industry, with particular strengths in high […]
Read More
  • Find a job
  • Apply
  • Get a job