Sr. Quality Engineer*

Job Description:

Sr. Quality Engineer

Collaborate with Innovative 3Mers Around the World

Choosing where to start and grow your career has a major impact on your professional and personal life, so it’s equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a diversity of people, global locations, technologies and products, 3M is a place where you can collaborate with 96,000 other curious, creative 3Mers.

“A long-lasting career at 3M comes from having vision, imagination and the ability to see what doesn’t exist. 3Mers are groundbreaking innovators and it’s important that we give every person the space for disruptive and creative thinking.” – John Banovetz, senior vice president and chief technology officer at 3M 

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

The Impact You’ll Make in this Role

The person hired for this position will provide Quality Engineering support for various programs in the Biopharmaceutical Processing Business within the SPSD Division.  This position would involve assignments to new product development programs, marketed products, and customer-facing interactions.  quality systems, and regulatory projects.  3M SPSD is an exciting growth business within 3M's Healthcare Business (HCBG) and a market leader in purification solutions. 

As a Sr. Quality Engineer, you will be focused on developing novel sustainable materials, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

  • Quality leader and core team member on New Product Introduction (NPI) projects.
  • Responsible for Quality Assurance (QA) support of related, marketed products.  Support activities include change management, customer complaint tracking/trending/monitoring, risk management, quality agreements, and quality improvement and compliance activities.
  • Review/approval of Process Validation (IQ/OQ/PQ) protocols and reports.
  • Review/authorize studies/data to validate our product claims.
  • Assuring compliance to internal Standard Operating Procedures (SOP's) and external standards.  Leading Corrective and Preventive Action (CAPA), Risk Management, Risk Reviews, and change control.
  • Representing the customer, evaluating customer complaints and issues, samples and trends, and determining the necessary action plans.
  • Interacting with and supporting our plant manufacturing locations (traveling to plant sites as necessary).
  • Helping to drive and foster a quality environment and mindset throughout the business. 

Your Skills and Expertise 

To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:

  • Bachelor’s degree or higher (completed and verified prior to start) from an accredited institution
  • Four (4) years of combined product, quality, engineering, manufacturing, microbiology, and/or laboratory/technical environment experience in a private, public, government or military environment

Additional qualifications that could help you succeed even further in this role include:

  • Bachelor’s degree or higher in Mechanical Engineering, Chemical Engineering, Statistics, Chemistry, Microbiology or related discipline from an accredited institution
  • Previous experience working in an FDA regulated device, combination, or drug environment
  • Ability to lead key Quality deliverables and execute in a timely fashion
  • Previous experience leading QA efforts for marketed products and new product introduction teams
  • Previous manufacturing plant experience
  • Ability to multi-task and prioritize
  • Strong analytical and problem-solving skills
  • Statistical knowledge and practice including: Gage Repeatability and Reproducibility (R&R) studies, Statistical Process Control (SPC) and Process Capability, Sampling Plans, Design of Experiments (DOE), Analysis of Variance (ANOVA) and Regression, Process and Product Understanding (PPU) and/or Lean Manufacturing]
  • Customer-facing/customer interaction experience
  • Risk Management and Test Method Validation Experience
  • Ability to identify opportunities for improvement and lead change
  • Minitab and Microsoft Office proficient

Travel:  May include up to 25% domestic/international

Relocation Assistance:  Is not authorized

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

Responsibilities of this position may include direct and/or indirect physical or logical access to information, systems, technologies subjected to the regulations/compliance with U.S. Export Control Laws. U.S. Export Control laws and U.S. Government Department of Defense contracts and sub-contracts impose certain restrictions on companies and their ability to share export-controlled and other technology and services with certain "non-U.S. persons" (persons who are not U.S. citizens or nationals, lawful permanent residents of the U.S., refugees, "Temporary Residents" (granted Amnesty or Special Agricultural Worker provisions), or persons granted asylum (but excluding persons in nonimmigrant status such as H-1B, L-1, F-1, etc.) or non-U.S. citizens. To comply with these laws, and in conjunction with the review of candidates for those positions within 3M that may present access to export controlled technical data, 3M must assess employees' U.S. person status, as well as citizenship(s). The questions asked in this application are intended to assess this and will be used for evaluation purposes only.  Failure to provide the necessary information in this regard will result in our inability to consider you further for this particular position.  The decision whether or not to file or pursue an export license application is at 3M Company's sole election.

Supporting Your Well-being 

3M offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope. 

Resources for You 

For more details on what happens before, during and after the interview process, check out the Insights for Candidates page at 3M.com

Learn more about 3M’s creative solutions to the world’s problems at www.3M.com or on Twitter @3M.Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.3M is an equal opportunity employer.  3M  will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

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Location
United States