Supplier Quality Engineer

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.