Engineer, Supplier Development Quality in Maplewood, MN at Volt

Date Posted: 6/19/2020

Job Snapshot

Job Description

Supplier Quality Engineer (12-month contract)
St. Paul, MN

Volt has partnered with a growing manufacturing cline in search of a Supplier Quality Engineer!

Job Description:

The EU MDR SQE will evaluate the supplier’s manufacturing process information, production risk management, against MDR Requirements; collaborate with the supplier to revise existing or develop manufacturing process information, production risk management for EU MDR submissions, as applicable.

Responsibilities:

  • Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information as required.
  • Cross coordinate activities/interdependencies with other workstream and project teams, as required.

• Support definition and clarification of supplier related process requirements for EU MDR submissions.

  • Support Review and Approval of supplier process validation protocols and reports as applicable.
  • Support the update of supplier related Inspection Criteria as applicable.

Requirements:

• A minimum of a bachelor’s degree or equivalent in engineering or associated technical field is required.

• A minimum of 1-year experience in a quality engineering is preferred.

• A minimum of 1-year experience in the medical device is preferred.

  • Familiarity with ISO 13485 and EU MDR is required.

• Excellent organizational skills and attention to detail is required.

• Must be able to work independently and prioritize with limited supervision.

• Strong written and oral communication and interpersonal (listening) skills.

• Excellent computer, communication, and written skills are required. Proficient in Microsoft Office suite is required.

Qualifications preferred:

• One - three years’ experience as Supplier Quality Engineer;

• Supplier Process Validations

• Project Engineer, Project Manager or equivalent role within regulated industry.

• Understanding supplier management and validation procedures and execution.

• Strong background in Medical Device Regulatory Compliance.

• Experience working with suppliers and cross functional team members.

• Ability to act as an SME in supplier business processes.

Volt is an Equal Opportunity Employer