Engineer, Quality in Maplewood, MN at Volt

Date Posted: 6/28/2020

Job Snapshot

Job Description

Quality Engineer (weekend shift – Friday to Sunday/12-hour shifts)

St. Paul, MN

Summary:

Provide Process/Quality Engineering support to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams.   Work effective with international site to support product transfer.  Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies/relationships.

Responsibilities:

  • Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
  • May be responsible for risk analyses and FMEAs.
  • Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
  • Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions.
  • May interact with vendors.(Planning/Organization) Plans and organizes non-routine tasks w/approval.  Organize FAT testing and provide guidance for equipment specification.
  • Establishes priorities of work assignments. (Decision Making/Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
  • Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
  • Provide guidance for alignment with ISO13485 and FDA 21 CFR 820
  • Develop Gage R&R documentation for manufacturing processes, systems, and equipment.  Develop, execute, and review test methods validation and design verification test plans.  Act as a liaison between Management and other teams supporting TMV activities.
  • Author, review and execute IQ, OQ, PQ, PPQ, MVP, and IQA for new equipment and when changing existing manufacturing equipment.
  • Must be able to support and provide direction to inspectors on the production lines.
  • Quality process support of tissue, sewing, testing, and sterilization operations.
  • Must be able to interact effectively with cross functional partners and represent operations quality. 
  • Must be able to work weekend hours – Friday to Sunday and 12 hr workdays. 

Qualifications:

  • Bachelor’s degree in Engineering or Sciences.

  • Seeks assistance for complex issues and exercises judgment within defined procedures and practices to determine appropriate action.

  • Demonstrates effective organization and prioritization.

  • Interacts well with diverse groups to maintain strong working relationships. Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.

  • Negotiates and reconciles differences to work well with others in a collaborative, fast-paced, goal-driven environment.

Volt is an Equal Opportunity Employer