Senior Quality Manager

Our client a major multinational based here in Galway are seeking aS enior Quality Manager (Complaint Investigation )on apermanent basisto join their team

The Role:

As the Senior Quality Manager you will interface with key internal stakeholders including Corporate, Site, and Business Unit representatives. You will work directly with operating entities to ensure that Post Market product complaint management processes are performed as required.

You will work closely with CCC and CMC managers to establish and ensure compliance with applicable regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13485:2003), company and department policies and procedures.

Responsibilities

• Act as an effective leader in supporting quality disciplines, decisions, and practices.
• Define and lead strategy advancement of technical insight and product performance improvement.
• Defining best approaches and statistical techniques to product performance during launch, sustainment, and EOL
• Develop and maintain Post Market Compliance programs, policies, and processes.
• Develop and implement department tools and methodologies pertaining to the product complaint management process to ensure compliance and to drive continuous improvement.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Drive projects of major magnitude and scope with value saving & compliance related opportunities.
• Recruit, coach, develop, and lead organizational talent.
• Manage product investigation workloads and processes to ensure timely investigation and escalations as required
• Provide oversight to work done offsite and by 3rd party vendors.
• Determine appropriate staff levels, schedules, and resources.
• Work cross-functionally and across sites to identify and resolve issues.

Requirements:

• Level 8, 240 credits, in Science or Engineering (Level 9 desirable)
• Leadership in problem-solving, process improvement across engineering, and cross-functional teams
• In depth knowledge of Quality Systems, Medical Device manufacturing and regulatory requirements over a minimum of 9 years.
• Experience achieving product improvement across organisation e.g. Post Market, DA, operations, supply chain, supplier, and field-based organizations.
• Strategic experience in technical failure analysis and/or data analytics
• Excel in Collaborative Leadership with the ability to influence.
• Experience in managing large-scale, complex operations/programs/projects with results.
• Experience with Quality systems and methods,products, customer needs & lean business/VIP experience.
• Financial experience in cost center planning and execution responsibility.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.