Medical Device Quality Manager

2 weeks ago

Houston, United States Enovis Full time

At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence — with the goal of transforming medical technology as we know it. Because that’s how we change the lives of patients for the better.

As the Quality Manager you will provide technical and administrative guidance to Quality Assurance, Quality Control, Manufacturing, and Suppliers of sourced product. Assures product conformance to established requirements and standards through appropriate inspection and test activities. Coordinates quality planning, inspection method development and defect prevention/corrective action processes for new and existing products. Identifies and solves product and process problems and supports various operational groups. Assists in the preparation and monitoring of the operating and capital budgets.

**Essential Duties and Responsibilities**:
The following are the primary duties and responsibilities of this role. Other related duties may be assigned to meet the business need.
- Lead incoming inspection and operations quality engineering teams
- Utilizing comprehensive knowledge of engineering and problem-solving principles, this position is responsible for a variety of complex activities regarding the design, implementation, and maintenance of quality assurance procedures and work instructions to ensure external safety, quality, and compliance with company standards and government regulations
- This position supports the incoming inspection department and works closely with suppliers and internal teams to reduce inspection burden while ensuring high product quality
- Supervise inspection personnel and formulate strategy to increase efficiencies in QC Department
- Supervise QA engineers responsible for supplier inspection and supporting internal manufacturing
- Assist the prioritization of daily schedules and work activities
- Review inspection strategies and techniques used on implant and instrument product
- Review inspection equipment programs for suitability
- Able to perform inspection activities to support team, as needed
- Partner with suppliers to develop inspection requirements to an extent that they are certified and able to perform the final inspection (dock-to-stock, skip lot)
- Author and execute supplier inspection certifications and validations
- Assist process capability for product qualifications to reduce inspection within manufacturing and inspection areas
- Support manufacturing to correct adverse quality or compliance issues
- Support and engage in quality system activities (e.g., management review, CAPA, design control, process control, change control, document control, label control) that ensure products conform to defined requirements
- Support regulatory inspections and verify that appropriate follow-up and corrective actions are developed and implemented
- Foster a positive employee environment by promoting open communication, engagement and development of team members
- Promotes a culture of trust, flexibility, teamwork and inclusion, ensuring all relevant functions are included in decision making processes as part of continuous improvement, problem solving and projects
- Create a highly talented team by recruiting, hiring, and developing individuals in positions aligned with their future potential. Ensures effective training and performance management of the teams
- Work closely and develops strong business relationships with key stakeholders in operations, commercial, and engineering management teams to help drive business success
- Determine and define quality assurance requirements from review of engineering drawings and/or specifications, industry standards, government specifications or other applicable source documents
- Formulate and maintain procedures, specifications, and standards for the quality control of products including; non-destructive testing methods, gauge design and procurement, sampling and inspection methods, and visual acceptance standards
- Coordinate the maintenance of the calibration program for all inspection tools and gauges to comply with division and corporate Good Manufacturing Practices
- Develop and administer effective data collection and reporting system to meet regulatory requirements
- Responsible for ensuring the control of nonconforming products until deficiency or unsatisfactory condition has been corrected
- Provide resources, including the assignment of trained personnel, for performance of work and assessment activities to meet requirements
- Implement defect prevention strategies utilizing SPC/SQC principles and practices

**Required Education and Experience**:

- Bachelor's degree in engineering or related discipline with a minimum of 4+ years of work experience within a quality function
- 2+ years of supervision/leadership experience
- Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required; preferred knowledge of ISO 1348

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