Product Assurance Engineer (Maplewood, MN)
Maplewood , Minnesota
October 18, 2017
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Job Description:

3M is seeking a Product Assurance Engineer for the Infection Prevention Division (IPD) located in Maplewood, MN. Here, we go.

Job Summary:
The Product Assurance Engineer hired for this position will own multiple commercialized product lines, with a focus on chemical indicators, and manage change control and quality improvements in our Device Reprocessing business. This individual will lead and support projects that appreciably impact quality, performance, service, and cost, and will collaborate cross-functionally to include manufacturing, regulatory, lab, business, and plant personnel.

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Primary Responsibilities include but are not limited to the following:
  • Drive existing product quality improvement through use of continuous improvement methods and tools, such as: Six Sigma, Product and Process Understanding (PPU), Design of Experiments (DOE), Customer Quality Index (CQI) and Quality at the Source.
  • Support and interact with customers through complaint investigations, resolution, and trending.
  • Ensure the commercialized product design intent and product integrity is retained as materials, processes, methods, and specifications change.
  • Lead and oversee change management as it relates to design changes driven by quality improvement, source of supply changes, or cost reduction efforts.
  • Lead trouble shooting, investigation, and analysis for non-conforming product testing and disposition.
  • Interact globally with 3M facilities for quality improvement or localization efforts.
  • Collaborate with regulatory, manufacturing, laboratory, clinical, tech service, plant personnel
  • Act as primary spokesperson for product performance and quality, and be the customer representative for assigned products within the plant facility.
  • Lead cross functional teams that include manufacturing, technical service and quality/regulatory engineers.
  • Support and/or lead efforts on life cycle management, risk management, product and process improvements, and other product documentation efforts.
  • Act as the primary product liaison between the plant and other divisional functions

Basic Qualifications:
  • Bachelor's degree or higher in a science or engineering discipline from an accredited university
  • Minimum of one (1) year of experience working in a technical area

Preferred Qualifications:
  • Bachelor's degree or higher in Chemistry, Chemical Engineering, Materials Science or related discipline from an accredited university
  • Minimum of three (3) years of experience in an adhesives and/or reactive chemistries related field
  • Experience running small scale investigative experimentation in a laboratory or pilot plant
  • Possess a sound quality and regulatory mindset
  • Project leadership experience
  • Minimum of one (1) year of Lean manufacturing experience with a working knowledge of PPU and Lean principles
  • Minimum of one (1) year of combined experience in a quality, technical, manufacturing and/or laboratory environment
  • Strong emphasis on applied statistical applications and continuous improvement methodologies
  • Experience in product quality assurance for regulated products
  • Experience working with quality systems applied to the health care industry (Medical Device ISO 13485, FDA QSR and Drug GMP)
  • Demonstrated experience to analyze problems, diagnose root cause and apply corrective actions
  • Strong analytical problem solving skills
  • Strong collaboration skills
  • Excellent verbal and written communication skills.
  • Self-driven with excellent organization and leadership skills

Location: Maplewood, MN
Travel: May include up to 15% domestic
Relocation: Is authorized

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

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