Description
*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.
- 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.
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