Director Quality Siemens Mishawaka

Job Description: • 2-minute read •
Maintain and oversee the associated activities for the Quality Management System for Point of Care (POC) manufacturing sites in Northern Indiana. This position includes responsibility for Corrective Action and Preventive Action (CAPA) program, Management Review, Quality Control, Audit program (internal, registrar and FDA), Document Control and Employee Training.

Manage Quality the team that supports all aspect of manufacturing including Process Quality, Supplier Quality, Quality Control, and Document Control. Interact with multiple functions within and outside of the site(s) including but not limited to Technical Operations, Manufacturing Operations, R&D, Regulatory, and Quality Compliance.

Drive quality Key Performance Indicators (KPIs) metrics and report results to management.
Establish process metric goals in partnership with functional leads.
Provide QMS Training to site population and share best practices across the project teams.
Liaison with Registrar/Notified body to ensure continued compliance to ISO certification.

Specific Requirements:
• Working knowledge of quality system requirements for medical device company with manufacturing focus.
• Manage issues that are complex with many competing priorities.
• Directs decision making on manufacturing quality issues using historical knowledge and FDA's current regulations on medical device industry.
• Advanced working knowledge of requirements for Process Validation, Internal Audit program, CAPA program, Nonconforming material management.
• Advanced knowledge of Quality System Requirements for medical devices.
• Develop and improve process flows, SOPs, forms and instructions to help streamline working practice
• Experience participating in and leading in multifunctional teams.
• Experience in communicating (oral & written) with third party regulatory agencies.
Education:
BS/BA in related discipline, or advanced degree, or equivalent combination of education and experience.
Experience:
• Typically 10+ years of successful experience in the Quality Systems field.
• Experience with FDA Quality System Regulations 21 CFR 820, ISO13485, and/or IVDD 98/79/EC.
• Experience in a medical device reagent or instrument manufacturing environment.
• Quality Manager Certification is a plus.
• SAP working knowledge is a plus.
Reporting Structure:
Report to Sr. Director of Operations – Site Head

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