Quality Engineer ∞ (Maplewood, MN)

Job description

Description du poste

3M is seeking a Quality Engineer for the Medical Solutions Division (MSD)  located in Maplewood, MN. At 3M, you can apply your talent in bold ways that matter.  Here, you go.

Job Summary :

The person hired for the position of Quality Engineer will own multiple commercialized products, with a focus on sterilization hardware and related consumables, 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.

For additional business group/division/product information, please visit:

https://www.3m.com/3M/en_US/company-us/all-3m-products/~/All-3M-Products/Sterilization-Monitoring/?N=5002385+8711017+8711099&rt=r3

This position provides an opportunity to transition from other private, public, government or military environments to a 3M career.

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.
·  Oversee outsourced suppliers to drive robust product quality and service.
·  Interact globally with 3M facilities to communicate progress and ensure alignment on quality improvement projects.
·  Collaborate with regulatory, manufacturing, laboratory, clinical, tech service, and plant personnel.
·  Act as primary spokesperson for product performance and quality, and be the customer representative for assigned products.
·  Support and/or lead efforts on life cycle management, risk management, product and process improvements, and other product documentation efforts.

Basic Qualifications:

·  Possess a Bachelor's degree or higher in an engineering or science discipline (completed and verified prior to start) from an accredited institution
·  Minimum two (2) years of combined experience in a Manufacturing/Production, Quality and/or Laboratory function within a private, public, government or military

Preferred Qualifications:

·  Bachelor’s degree in Mechanical Engineering or Chemical Engineering, Materials Science or related discipline from an accredited institution
·  Minimum of two (2) year of experience working in a quality function, manufacturing/production plant, and/or with hardware components
·  Experience running small scale investigative experimentation in a laboratory or pilot plant
·  Possess a sound quality and regulatory mindset
·  Project leadership experience
·  Strong emphasis on applied statistical applications and continuous improvement methodologies.
·  Experience in product quality assurance and quality systems for regulated products, ideally applied to the health care industry [Medical Device International Organization for Standardization (ISO) 13485, Food and Drug Administration (FDA) Quality System Regulation (QSR) and/or 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
·  Experience working on a cross functional team
·  Excellent communication skills (oral, written and presentation)

Location: Maplewood, MN

Travel: May include up to 15% domestic/international

Relocation: Is not authorized

                                                 

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