Internal Audit ofertas em United States

Job Description

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
• 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
• Must have attention to detail and strong verbal and written communication

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 era.

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.