Provide Quality Engineering leadership for the design and development of spine implants and related instrumentation, and development and improvement of associated manufacturing. Provide Quality Engineering leadership for the design and development of spine implants and related instrumentation, and development and improvement of associated manufacturing processes. This involves working closely with Advanced Operations and Product Development on new product development teams, and active participation in continuous quality improvement activities. Minimal to no supervision required.
Work closely with Advanced 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 via leading the Risk Management process.
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 for new products.
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 for concessions.
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 Clients's Business Process Excellence initiative.
Serves as mentor to other quality and reliability engineers
5 or more years of Quality Engineering experience. Validation experience is a plus.
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 is a plus.
Ability to effectively work cross-functionally with Product Development, Operations and Marketing.
Excellent problem solving and troubleshooting skills.
Excellent interpersonal and communication skills.
Must be a positive, energetic team player, and an advocate for product excellence and quality.
Candidate must be results oriented, multi-tasking, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines.
Seniors will need to have demonstrated sustained exceptional performance and /or have more experience in a large role