Design Assurance Manager

Recruiter
Merit Medical
Employment Type
Permanent
Salary
Not disclosed
Merit Medical logo

Why Merit?
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

Key Benefits
•Attractive Salary package
•Defined Contribution Pension Plan
•Health Insurance Cover
•Life assurance
• Health & Wellbeing Events Calendar
• Excellent career progression opportunities
• Recognition scheme
• Free Parking
• Educational assistance
• Internal training courses
• Quality Subsidised Canteens & Barista Service
• Active Sports and Social Club

We are Global

Merit Medical Galway commenced with 22 employees in 1993. Since then Merit has enjoyed year on year revenue growth and developed its workforce to over 900 employees. Headquartered in Salt Lake City, Utah, Merit maintains a diverse, multi-campus manufacturing footprint in Europe, North America, South America, Asia and Australia with a global distribution.

Medtech Company of the Year Winner

Merit Medical Galway are proud winners of the Medtech Company of the Year Award, a prestigious award recognizing those who are exceling in the MedTech industry.

People Development

At Merit Medical Galway almost 60% of all roles are filled by internal employees! We focus on encouraging, believing in and providing a platform for you to progress your career!

Culture

A supportive and collaborative environment make Merit Medical a friendly, enjoyable place to work. We are proud of our energetic and dynamic culture. Diversity & Inclusion is evident here with an 50/50 ratio of male and female employees as well as 30 nationalities onsite! We value every employee as an individual.

JOB PURPOSE

Provide management support and leadership for all Quality Assurance personnel and provide technical support for the design and development of new products, remediation and changes to existing products.

The successful candidate will work closely with groups across Merit sites including Clinical, Medical and Corporate support.

SUMMARY OF DUTIES

  • Provide direction, management support and leadership for the following quality functions/programs:
    • Design / new technology assurance.
    • Compliance to Regulation.
    • Post Market Surveillance.
    • Management review.
    • Internal / external quality audit.
    • Real time aging.
    • Risk management.
    • Validation review (product & process).
  • Functional manager for a team of quality assurance personnel:
  • Resource functional areas.
  • Select, coordinate and assign work.
  • Mentor employees and manage performance for all team members.
  • Manage training and career developmental needs.
  • Develop budgets for the Quality Assurance department.
  • Provide technical support for the manufacture of existing products and the growth and development / transfer of new products / technologies.
  • Partner with Research and Development (Product & Technology) function ensuring:
  • Customer requirements are met.
  • Safe and effective product design.
  • Compliance with design control requirement.
  • Design for manufacture.
  • Quality at source.
  • Smooth transition of new products and technologies to operations groups.
  • Participate, support and provide independent review of all verification and validation activities.
  • Provide Merit Medical with recommendations and decisions which uphold company and regulatory standards in furnishing quality products to the customer by:
  • Developing and directing annual ‘Quality Assurance” team goals to ensure continuous growth of personnel and delivery of key company objectives as defined in the business excellence plan.
  • Reviewing performance of Quality Assurance staff in achieving compliance and system improvement objectives.
  • Preparing or reviewing written procedures and documentation for testing and the manufacturing processes.
  • Tracking information about customer complaints to provide design, development and operations teams with product quality information.
  • Providing recommendations and decisions regarding the disposition of non-conforming products; determines when Regulatory/Clinical approval is required; stops production lines if problems with quality arise and initiates preventive and corrective actions to ensure non-recurrence.
  • Coordinating Emergency Management Team (EMT) meetings and participating/managing product investigations.
  • Identify opportunities to improve organisational systems and processes to save costs, improve efficiency, maintain compliance, increase the value of products or increase customer satisfaction.
  • Promote and support the business excellence program, leading by example. Partner with functional leaders to ensure that this program and the organisation values are at the forefront of decision making and action.
  • Partner with Merit Medical Systems Inc. (Corporate) and other Merit Medical sites in the development of systems for standard business and quality processes.
  • Perform a variety of management related tasks to ensure that quality improvements are achieved as required.
  • Ensure compliance with GMP and GDP requirements for medical devices and medicinal products.

EDUCATION & QUALIFICATIONS

  • Degree in Quality Engineering/Engineering/ Science or equivalent qualification essential (NFQ Level 7, or higher). Post graduate diploma/Masters in Quality Management desirable.
  • 10 Years (• ) of related work experience of which at least four years’ experience is in the medical device manufacturing industry in a similar role, coupled with a proven track record in leadership and development of a large team.
  • Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), ISO 13485 Quality System Standard, ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR), JPAL/JGMP and Medicines Directive 2001/83/EC.

Merit Medical is an Equal Opportunities Employer

To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
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