Job Title
Join the Metals Core Technology (MCT) Quality team in Maple Grove, Minnesota, to improve patients' lives and make a meaningful impact on those around you. In this dynamic production environment, you will have the technical autonomy to drive innovation, strengthen manufacturing processes and help transform customer experiences globally. In this role, you will collaborate with manufacturing engineers on line support activities and partner with product development teams to help ensure the development of robust new products. The incumbent will oversee multiple manufacturing processes on the production line and work cross-functionally with manufacturing engineering and production teams to achieve business unit objectives while providing quality leadership to the team.
Your Responsibilities Will Include:
- Identify and implement effective process control systems to support the development, qualification and ongoing manufacturing of products that meet or exceed internal and external requirements.
- Support a culture of continuous improvement by driving enhancements to existing process controls.
- Proactively investigate, identify and implement best-in-class quality engineering practices.
- Promote quality assurance, process controls and corrective and preventive action (CAPA) systems designed to meet or exceed internal and external requirements.
- Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues.
- Actively engage with production teams across all four shifts to develop solutions that improve outgoing quality.
- Provide input on and implement departmental and cross-functional engineering initiatives.
- Provide project direction, coaching and mentoring to technician team personnel.
- Perform process validation and verification activities and review related documentation.
Required Qualifications:
- Bachelor's degree in engineering, science or a related field.
- Minimum of 3 years' experience in a relevant field, including experience with process validation and verification activities and risk management documentation, such as design failure mode and effects analyses (DFMEAs) and process failure mode and effects analyses (PFMEAs).
- Strong data analysis skills using tools such as Excel and Minitab.
- Proven ability to work successfully with minimal supervision and take initiative.
- Ability to manage multiple priorities and meet deadlines while maintaining strong attention to detail.
Preferred Qualifications:
- Experience owning nonconformance investigations, process improvement initiatives and corrective action projects.
- Experience leading cross-functional teams and driving projects to completion.
- Experience in the medical device industry or another highly regulated industry.
- Experience providing quality line support.
- Experience working in a manufacturing environment.
Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.