Job DescriptionJOB SUMMARY: Supervises a team of Product Quality Technicians and Return Good Technicians who identify, investigate, plan and conduct activities to improve and assure quality design and manufacturing of medical devices and components. This role collaborates with product engineering, production, supply chain and quality to bridge the gap with respect to quality improvements, compliance and cost management. Requires a level of experience and judgment to plan and accomplish goals, a certain degree of creativity and latitude is required. ESSENTIAL/PRIMARY DUTIES:
- Adheres to Midmark core beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
- Develops, maintains and improves the quality management system for supplier controls, NCMR, and return goods to ensure compliance to the FDA Quality System Regulation and international requirements such as ISO 13485 and ISO 90001.
- Plans and conducts activities concerned with the quality assurance by working closely with suppliers, manufacturing, purchasing, customer service and supplier quality.
- Monitors initial performance and initiates corrective actions, as required.
- Supervises and investigates product quality issues and works directly with suppliers (internal or external) to ensure appropriate containment steps and corrective actions are taken in a timely manner. Works with suppliers to confirm corrective action plans are effective.
- Collects supplier quality/delivery data, creates (plant-specific) supplier scorecards, and submits performance reports for review/consolidation at the corporate level.
- Identifies and resolves specification alignment issues between manufacturing (process) requirements and supplied or manufactured product. Facilitates resolution of MRB issues.
- Ensures that all tasks are conducted in accordance with the Midmark Quality System procedures.
- Applies Midmark Production System (MPS) concepts to identify and eliminate non-value-added tasks and/or activities in the various areas of responsibility.
- Directs the continued review of quality activities and the creation of new or revised processes to ensure quality improvements reduce costs and enhance efficiency.
- Maintains effective working relationships with internal and external customers and suppliers.
- Develops and recommends revisions or enhancements to schedules, human and monetary resource allocations, and production requirements.
- Assists in analyzing and reviewing budgets, schedules, production requirements and headcount to determine the most cost effective and efficient methods of obtaining necessary resources.
- Creates a strong and accountable Quality team through the coaching and leading of supervisory staff, and the hiring and planned development of team members.
SECONDARY DUTIES:
- Works closely with the manufacturing engineers, inspection, and purchasing groups to identify, monitor, and prioritize supplier improvement needs.
- Leads and directs regular visits/audits to assigned suppliers to review manufacturing processes, quality systems/controls, pre-launch readiness, root cause identification, corrective actions, and process improvement opportunities.
- Performs other functions as required.
EDUCATION and/or EXPERIENCE: Bachelor's degree from a four-year college or university and 5+ years of relative experience, or equivalent combination of education and experience. Quality or engineering experience, preferred. COMPETENCY/SKILL REQUIREMENTS:
- Familiar with standard concepts, practices, and procedures within supplier quality and returned goods
- A high level of business acumen and comfort working in a cross functional environment
- Excellent communication (written/verbal) and interpersonal skills with ability to influence
- Strong analytical capability with demonstrated adeptness at problem solving and ability to not only view details but also understand big picture implications
- Process oriented, proactive and customer-focused
- Familiarity with ISO 13485 and 21 CFR 820 especially on purchasing controls, production and process controls, and customer related processes
- Familiarity with process validation and test method qualification
- Auditing to Quality Systems and Manufacturing processes
- Root cause investigation
SUPERVISORY RESPONSIBILITIES:
- Leads and directs the work of other teammates and typically has some authority for personnel decisions related to hiring, performance, or disciplinary actions
About Us 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. EO/AA Employer Minorities/Females/Protected Veterans/Disabled