Quality Engineer II
Inginaire is currently looking for a Quality Engineer II for our client in Brooklyn Park, MN. Our client is the world leader in Medical Device Technology and Therapies. The person in this position will be responsible for actively partnering with suppliers and establishing/agreeing upon expectations up front. They will ensure supplier processes are robust, and monitored/reported per required procedures. This is a long-term contract opportunity.
- Develop a strong relationship with supplier.
- Develop a robust risk management process for each supplier.
- Drive continuous improvements in the Supplier Quality organization by continuing to improve related systems and processes in Structural Heart.
- Work to continue to harmonize and improve processes and practices with all businesses in Structural Heart.
- Work with the supplier base to drive corrective/preventative action based on feedback from incoming inspection, manufacturing floor and contract manufacturers.
- Lead improvements efforts as appropriate.
- Drive supplier improvement/corrective actions based on supplier performance trends.
- Develop characterization and qualification strategies, protocols and reports (including structured DOE evaluation and/or IQ/OQ/PQ/PV documentation)
- Provide technical assistance to suppliers/other resources performing qualification/validation testing. Assure the resolution of all issues raised during testing
- Work with suppliers to resolve supplier related defects to assure that corrective actions are developed and implemented using NCMR, SCAPA and CAPA processes.
- Oversee Supplier Change Control. This will include preparing and releasing change orders.
- Establish and create Supplier Quality Agreements with key suppliers based upon business and product risk.
- Develop and maintain strong working relationship with functional groups (R&D, supply chain, supplier quality and regulatory) at various Medtronic sites.
- Develops and implements systems and processes for supplier management that are in compliance with corporate policies, FDA?s QSRs, ISO 9001, IVDD, AIMDD, CMDCAS, CMDR, ISO 13485, MDD/EN46001 and other quality requirements, regulations and guidelines.
- Drive sub-tier supplier requirements and monitoring as defined in the risk management assessments.
- Lead or participate in the audit/assessment of current or future suppliers ensuring they are compliant with associated Medtronic policies and GMP/ISO requirements.
- Provide input into the design, reliability, and manufacturability of new products and coordinate activities within our supplier base. Work closely with component engineers to ensure supplier practices are used across the business.
- Provide statistical support by the creation of supplier related metrics for the purposes of tracking vendor performance and identifying opportunities for supply chain improvements.
- BS/BA degree in engineering or science
- 3-5 years related engineering experience, with a minimum of 2 years experience in Supplier Quality
- Minimum of 1-2 years in Medical Device Industry
- Experience in the Medical Device Industry
- Oral and Written communication skills
- Ability to work in a team/partnership environment
- Computer Skills (Microsoft- Word, Excel, Project, PowerPoint, Minitab)
- Use and understanding of Statistical Tools (Design of Experiments, Measurement System Analysis, Process Capability and Statistical Process Control)
- Ability read part prints and component specifications
- Understanding of Geometric Dimesional Tolerancing (GDT)
- Project Management experience
- Manufacturing experinece in Injection molding materials, process development tool design and visual standards
- 3-5 years experience in Supplier Quality
- MS degree in science or engineering