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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

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 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.

 

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 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.

 

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