QA Manager

We Make Life More Rewarding and Dignified  Location: Ballina  Department:   Title:     Quality Assurance Manager   Hierarchical Level:          Manager   Division/Department:    Quality Assurance   Reports to:         Senior Manager Quality Assurance, Ostomy/Continence Care   Number of Direct Reports:         4   Travel:   10% time Domestic & International   Summary: The position will provide QA leadership and vision as part of a cross functional Plant Leadership Team, striving for a dynamic Culture of Quality to continuously improve our products, processes and Quality Management System (QMS) to best fulfil our Mission and Vision and make life more rewarding and dignified for the people who use our products. They will support both the Ballina manufacturing facility and the global Quality organization to achieve business objectives.   Responsibilities: The Quality Assurance (QA) Manager will directly oversee the activity of the QA department and staff. As part of this responsibility, they will generate and maintain a plan for the professional development and coaching of all direct reports including annual goal setting. Develop and maintain an overall strategy for their QA function ensuring communication to key stakeholders for alignment. Responsibility for developing, implementing, and maintaining the QMS  for the organizations products and processes ensuring audit readiness and compliance is maintained in line with required standards, regulations and company procedures. Quality oversight for raw materials, packaging components, in-process and finished goods product release. Quality Oversight for change control, complaints, internal audit, risk management, notified body/health authority external audits. Quality oversight for validation activities linked to process, equipment and computer systems. Quality oversight for the introduction of changes to existing products and of new innovative products. Support and lead on the sites operational excellence program ensuring the quality function work towards efficient and effective processes. Provide QA technical direction and guidance to achieve company objectives. Responsibility for preparation and management of the QA operating budget in conjunction with the Operations and Finance functions. Collaborate with manufacturing to ensure achievement of existing quality levels of manufactured products and seek methods to continually improve quality outcomes including leading on cost of quality initiatives. Decision making authority with respect to product quality in consultation with key stakeholders. Participate in Plant Leadership Meetings as required. As part of Hollister’s Global Quality Leadership Team (QLT), the position holder will attend QLT meetings as required. Represent the site as Management Representative/Authorized Representative/Person Responsible for Regulatory Compliance as outlined in Medical Device regulations if required. Other duties as required. Work Experience Requirements Number of Overall Years Necessary: 8-12 5+ years’ experience in a Medical Device/Pharma Industry in a Quality Leadership role that includes personnel and Quality System leadership. Education Requirements Third Level degree in Quality/Science/Engineering or a related discipline is required. Advanced degree is desirable. Specialized Skills/Technical Knowledge: Thorough Knowledge of Quality Management system elements and associated regulatory requirements (ISO 13485, ISO 14971, FDA 820.30, MDD/MDR etc.). Knowledge of internal & external audit management with proven experience in representing a company in interactions with notified body/Regulatory agencies. Good working knowledge of continuous improvement and root cause problem solving in a manufacturing setting. Demonstrated ability to project manage and execute tasks in a timely and efficient manner. Must be able to communicate (both written and verbal) at all levels of the organization and with customers, suppliers and regulatory agencies. Good interpersonal skills with the ability to work as part of a cross functional team. Excellent analytical skills with an ability to define problems, analyze through data collection/fact finding and draw valid conclusions in a timely manner. Have a continuous improvement mindset and demonstrated change management skills.             Hollister is an EO employer – M/F/Veteran/Disability Job Req ID: 33427