Quality Manager – Healthcare Business

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We are seeking a seasoned professional to join our Industrial Solutions business on a full-time, direct basis as our Quality Manager at our facility in Hemlock, MI.  We are looking for a highly-motivated Leader to support Quality Improvement initiatives (short-term & long-term) for our Liveo™ Healthcare operations; this involves supporting our customers and production sites.

This person will define strategic direction and manage quality activities for local Healthcare Industries Materials Site [HIMS] operations as well as contract manufacturers (globally); this involves providing direction & objectives to meet customer quality needs and assure compliance to applicable regulations (including U.S. Food & Drug Administration [FDA] guidelines).  This person will also drive improvements to the Quality Management System [QMS] to meet healthcare market quality requirements (including Current Good Manufacturing Practice [cGMP] standards).  This person will provide leadership while maintaining accountability for all Quality activities within the business unit (including the QMS, customer satisfaction, quality certifications, quality-related aspects of supplier relationships, training, quality audits, and Corrective and Preventive Action [CAPA] initiatives.  This person will also work closely with Senior Business Management to drive continuous quality improvement.

PRIMARY DUTIES & RESPONSIBILITIES:

• Define Quality objectives to meet business long-term goals and customer requirements for the Liveo™ healthcare business; this involves working across the local operations and contract manufacturers.
• Ensure the quality requirements for relevant quality standards (e.g.:  ISO-9001:2015, ISO-13485:2016, etc.) are implemented and maintained in accordance with cGMP (US 21 CFR 820) and FDA regulations.
• Lead the overall Liveo™ Quality unit, especially with people leadership and mentoring of the Quality Team.
• Work in a highly-matrixed and geographically-diverse business environment.
• Develop and deliver cGMP & quality training to all required personnel involved with manufacturing healthcare products.
• Negotiate and approve Quality Agreements.
• Interact with clients; this person will ensure customer complaints & inquiries are effectively addressed in a timely manner.
• Manage quality-related customer communication and assure proper customer change notification workflows are followed.
• Proactively seek global alignment / interpretation in application of relevant policies & procedures.
• Work closely with the Commercial and Technical Organization on improvement plans for the business.
• Establish quality goals for the site and contract partners.
• Support quality activities for Technical Service & Development [TS&D] as well as New Product Development [NPD] initiatives.
• Develop Roadmap(s) for Future Harmonized processes in the Quality Organization and cross-functional teams.
• Foster a safety-first mentality while improving efficiency through the improvement of process flow, elimination of waste, and cost reduction (through leadership, example, and training).
• Ensure critical suppliers are held to the highest standards and are monitored appropriately through audit programs.
• Oversee the Computerized Quality System Software Validation to ensure new systems and system changes are managed consistently with regulatory & business requirements.
• Support cross-functional Quality Management Reviews.
• Additional duties may be assigned, as needed.

QUALIFICATIONS:

Basic Requirements:

• Bachelor’s degree.
• 5+ years of professional experience working in Quality and/or Industrial Operations.

Preferred Qualifications:

• Completion of a degree in a technical field of study (e.g.:  Industrial Engineering, Chemistry, etc.).
• Relevant credentials (e.g.:  ISO Lead Auditor Certification, Six Sigma Green Belt (or higher), etc.).
• Experience working in a process manufacturing environment, preferably in a regulated industry (e.g.:  medical, pharmaceutical, etc.).
• Broad experience working with various areas of industrial quality:  Quality Assurance [QA], Quality C