- 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
- 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 13485 quality standards
- Familiar with quality control methods, including; non destructive testing, metrology, statistical process
- control, calculating quality costs, and inspection report creation
- Ability to use inspection measuring equipment, including: calipers, micrometers, gages, and other
- computerized measuring equipment (CMM, Oasis, Vision X, Keyence) is a plus
- Basic knowledge of manufacturing processes: key focus into metrology, precision machining, grinding,
- product cleaning, and sterilization
- Required and demonstrated knowledge of Microsoft Office Suite
- Preferred knowledge of the following software packages: Solidworks, NetSuite, Agile PLM.
- Quality discipline certifications a plus, including: CQE, CQA, Lean, 6 Sigma Certification (Green or
- Yellow Belt), or experience and knowledge of continuous improvement methodology
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Spending and Savings Accounts
- 401(k) Plan
- Vacation, Sick Leave, and Holidays
- Income Protection Plans
- Discounted Insurance Rates
- Legal Services
ABOUT ENOVIS™