The Supplier Quality Engineer will develop, maintain and support supplier quality assurance efforts to ensure that products and services meet specification requirements for components and assemblies. This role will communicate with suppliers to provide technical input and guidance to resolve quality issues.
How you will make an impact?
- Drive supplier development and lead continuous improvement initiatives with engineering team.
- Drive closure of quality improvement plans and activities.
- Provide supplier quality representation across DEKA.
- Manage Suppliers and Supplier Qualifications per applicable DEKA supplier quality procedures.
- Manage the Supplier Corrective and Preventive Action requests and responses including:
- Resolve supplier quality issues and perform/implement root cause and corrective actions with suppliers as needed.
- Investigate the nature and causes of nonconforming material to establish positive relationships and cultivate good faith amongst suppliers when pursuing external corrective actions.
- Manage and participate in Supplier Management Committee reviews.
- Provide input to the Engineering and Supply Chain teams in the identification, selection and qualification of suppliers.
- Work with Supply Chain, Engineering, and Incoming Inspection to monitor supplier performance as part of the ongoing management of DEKA’s Approved Supplier List.
- Facilitate the review and approval of supplier-initiated changes and communicate the approved changes to the appropriate departments.
- Work closely with suppliers to establish appropriate quality processes to meet any unique DEKA requirements.
- Look for opportunities to drive preventive actions and continuous process improvement with our suppliers.
- Support external and internal audits.
- Conduct supplier audits to assess supplier capabilities, opportunities for supply chain development, and overall compliance to the DEKA QMS.
- Conduct supplier auditor training, and provide DEKA wide training for supplier management processes.
What you will need to be successful:
- Bachelor’s in Engineering
- 3-4+ years of experience in a medical device R&D / manufacturing environment preferred
- Familiarity with ISO 13485:2016 and FDA 21 CFR Part 820
- Hands-on experience in Supplier Qualification, Supplier Audits, and Supplier Corrective Action.
- Strong investigation and root cause analysis skills and driven to fully and completely resolve problems.
- Ability to work with cross-functional teams.
- Managing Corrective and Preventive Action with suppliers
- Participate in compliance and regulatory audits and inspections
- Desired active passport
- Ability to work with CAD files and interpret mechanical drawings.
- Ability to analyze data for accuracy and correctly interpret results.
- Microsoft Office proficiency
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
What We Do
DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time. For over thirty years, DEKA Research & Development Corp. has made Manchester, New Hampshire home. Located about an hour from Boston, the beach, and the mountains, we are situated in the beautiful and historic Amoskeag Millyard buildings located in downtown Manchester.
DEKA continues to be a place where no idea seems too big and where creativity and crazy cool gizmos reign supreme. The engineers, technicians, machinists, designers and all of the other folks who make up DEKA are some of the most creative and innovative professionals you could ever hope to meet. It's a place where one crazy idea can end up being the next greatest invention. At DEKA we embrace the spirit of innovation and constantly aim to turn the impossible into a reality.
DEKA is filled with people who are driven to be among the best and brightest in their field of work. It’s a concentrated bunch of really smart thinkers, doers and problems solvers, who are driven to using innovative design solutions and state-of-the-art technology to improve lives. We all see endless possibilities in the power of technology to do good. Employees have the opportunity to work on diverse projects that have a positive, enduring impact on millions of people worldwide. We are growing! We're always seeking passionate individuals to join our growing team of evolved thinkers.
