Great opportunity for a Snr Quality professional to join a rapidly expanding regulated multinational in the Mid-West.
Overview : Manage team to ensure smooth and continuous operations of site quality system, quality control and assurance inspection for in process and finished goods. Oversee process audits and final product release documentation. Advise and facilitate failure investigations, compliance methodologies for manufacturing of valve assemblies
Duties and Responsibilities:
Manage supervisors, managers, and/or experienced professionals and activities including quality control, exception handling, process audits to achieve release and compliance expectations. Drive quality culture and engage staff morale. Develop a robust talent development plan in alignment with functional growth strategies of the department.
Plan and direct multiple complex quality assurance projects (e.g., CAPA) with the accountability for successful completion of all project deliverables to the business within established schedule, scope, and quality objectives. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups
Negotiate solutions and reaching consensus with cross-functional groups to drive business line continuity and/or continuous improvement of quality assurance areas
Responsible for inspection of in-process and finished goods, assemblies and components including proper implementation
Interface with cross-functional teams (e.g., Manufacturing Operations, Supply Chain, and Engineering) to ensure tactical execution of business objectives
Provide recommendations and implement workforce planning
Lead efforts to optimize business processes and systems by assessing business needs and developing, proposing and implementing technology solution options.
Act as a Subject Matter Expert (SME) in business processes in the area of responsibility. Define effective and efficient business process workflow, including process modifications in partnership with stakeholders
Education and Experience:
Bachelor's Degree in a related field
Experience in managing internal audit programs and inspections/audits by external regulatory agencies for class II/III medical devices Required
Demonstrated track record in people management/leadership Required
Experience working in a regulated industry Preferred
For a confidential discussion and more information on the role, please contact Rory Walsh.