Provide Quality Engineering leadership on the quality engineering side for the ShapeMatch custom cutting guide in our Orthopaedics division. Work closely with Operations, Advanced Operations and Product Development on new product development teams, and active participation in continuous quality improvement activities. Minimal to no supervision.
•Work closely with Operations to resolve in-house and supplier quality problems using established problem solving methodologies (Root Cause Analysis, Mistake-Proofing, etc). •Actively participate and lead on new product development teams to support product and process design and development activities. •Lead and Participate in the development and improvement of the manufacturing processes for existing and new products. Review and approve inspection plans, routers and product drawings. •Lead in development, review and approval of process and equipment validation/qualifications (IQ, OQ & PQ). •Interface with Suppliers for new processes, quality issues and process improvements for assigned projects. •Support product transfers to other plants/facilities. •Review/approve nonconforming material and system documentation. •Review/approve product and process change control documentation and specifications. •Lead and Participation in continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker Orthopaedics Business Process Excellence initiative. •Serve as mentor to others.
Qualifications/Work Experience
•5 years of Quality Engineering experience. Prefer validation experience. •Prefer demonstrated expertise in FDA and international medical device regulations, and the application of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, SPC, Root Cause Analysis, Mistake Proofing/Poka-Yoke. •Ability to work cross-functionally with Product Development, Operations and Marketing. •Demonstrated problem solving and troubleshooting skills. •Demonstrated interpersonal and communication skills. •Must be a positive, energetic team player, and an advocate for product excellence and quality. •Ability to multi-task, be results oriented, a quick learner and able respond to the needs of the team. •Demonstrated track record of meeting deadlines. •Demonstrated sustained performance and /or have more experience in a large roll.
