Quality Control Manager

JOB SUMMARY:

Manages the processes and teammates which identify, investigate, plan and conduct activities to improve and assure quality design and manufacturing of medical devices and components.  Is responsible to bridge the gap between product engineering, production, supply chain and quality with respect to quality improvements, compliance and cost management.  Manages multiple sites and remote teammates as needed to ensure quality processes and tools are used across the organization.

ESSENTIAL/PRIMARY DUTIES:

• Manage processes to ensure that the design, and design changes, complies with all specified regulatory agencies. (FDA, ISO, UL, CSA, etc.)
• Lead daily activities in making decisions and/or providing technical data for decisions that impact compliance with design specifications.
• Develops, maintains and improves the quality management system to ensure compliance to all specified regulatory agencies.
• Recommend, develop and implement programs designed to improve quality of the product.
• Oversee risk analysis through such tools as FMEAs, DOEs, capability analysis, etc.
• Manage activities in Item Qualification/Commercialization activities from protocol development, to testing, to a completed final report.
• Actively engaged in mentoring Co-Ops and new hires.
• Compile and reporting quality metrics to upper management.
• Directs and implements programs to reduce customer complaints, warranty, scrap, rework and other applicable quality metrics.  Establishes the Product Improvement Team (PI Team)
• May be responsible for the Quality Control labs or technicians for on-going support and strategic growth.  Quality Control labs lead incoming, in-process, final and first article inspections as well as the calibration program and device history record (DHR) reviews.
• Development and organization of people with expanding capabilities. Coach, develop and train direct reports
• Lead objective and key result (OKR) initiatives for process improvement, automation and teammate development across all applicable facilities.
• Participate in the Design Control process (Design Input, Design Output, Reviews, Qualification, Validation, etc.) including feeding lessons learned from the PI Teams into Next Gen projects.

SECONDARY DUTIES:

• Participates in product quality council and other discussions of product quality with sales, marketing, technical service and others.
• Support the Six Sigma Program Lead with training material development, pipeline of trainees and continuous improvement projects.
• Ensures the use of Six Sigma DMAIC tools are used appropriately to make data driven decisions.
• Manages department budget.

EDUCATION and/or EXPERIENCE:

• Bachelor Degree in Manufacturing or Mechanical Engineering or a technical related degree, with 10 years’ experience in a quality or engineering role, management experience preferred

COMPETENCY/SKILL REQUIREMENTS:

• Oracle (ERP)
• Minitab, R, or other statistical analysis program(s)
• Thorough knowledge of regulatory requirements and agencies including FDA and ISO preferred
• Six Sigma DMAIC
• CREO (Pro/E) – Desired
• Six Sigma DMADV & Reliability – Desired

SUPERVISORY RESPONSIBILITIES:

• Quality Engineers
• Quality Control Lab Supervisor, Technicians and/or Inspectors

Founded in 1915, Midmark Corporation is the only company transforming healthcare experiences through innovative design within the medical, dental and animal health environments. With more than 2,200 teammates worldwide, Midmark focuses on harmonizing space, technology and workflows, creating a better experience for caregivers and patients at the point of care. The Midmark headquarters and innovation hub are located in Versailles, Ohio, which is also home to the Midmark Experience Center, Design Center, Technology Center and our largest manufacturing facility. Midmark maintains eleven additional locations in the United States, including four innovation hubs, and has subsidiaries in India and Italy.

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