Quality Engineer

1 month ago

Eden Prairie, Minnesota, United States stratasys Full time

Stratasys is a world leader in 3D printing

Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products and healthcare. Through smart and connected 3D printers, polymer materials, a software ecosystem, and parts on demand, Stratasys solutions deliver competitive advantages at every stage in the product value chain. The world's leading organizations turn to Stratasys to transform product design, bring agility to manufacturing and supply chains, and improve patient care.

The Quality Engineer will provide ongoing quality support to manufacturing with a focus to prevent product manufacturing variability from affecting product performance with customers. This position will also engage in supplier quality, new product introduction (NPI) and Continuous Improvement (CI) for both product and process.

What you will be doing:

Quality Engineering

  • Compliance - Responsible as the key liaison between operations, suppliers, and the customer, ensuring that overall specifications, quality/regulatory requirements, and expectations are met for manufactured product. Communicate significant issues and/or risk identified during quality activities.
  • Non-Conformances - Collaborate with engineering and productions teams to investigate and resolve quality and compliance issues. Use data and problem solving tools to determine and implement corrective action (RCCA).
  • CAPA - Lead or participate in corrective/preventative action teams in resolving production, customer, and supplier issues (nonconformances, CAPA activities, and audit findings).
  • Supplier Quality - Support the investigation and resolution of issues related to suppliers. Support activities such as evaluations, FAI, material sourcing and qualifications. Assist with supplier audits and reviews.
  • Test and Inspection – Understand and implement protocols and methods to inspect and test in-process raw materials and finished products; Respond to and disposition defects or failures. Collaborate with Lab Inspection & Test team to address questions, concerns and opportunities for improvement.
  • Trend & Data Analysis – Use data to identify root cause and prioritize improvement in the inspection of finished products, in-process materials and bulk raw materials and recommend corrective actions when necessary.
  • Evaluate and analyze the efforts in organizing, documenting, and interpreting inspection support documents and records.

Continuation Engineering

  • Support projects by providing input for process improvement and help develop tactical approaches to implement team strategies.
  • Support on validation and qualification activities.
  • Review/update SOPs.

Must have for this role:

  • Bachelor's degree in Engineering, similar field or equivalent experience
  • 2+ years Quality Engineering experience
  • Knowledge of and experience with materials properties and processing, preferably polymer-related
  • Experience working in regulated environment and knowledge of ISO9001
  • Proficient in performing & facilitating Root Cause Analysis (RCA) and CAPA activities.
  • Basic working knowledge of Statistical Process Control (SPC), statistical analysis and trend analysis.
  • Ability to create and update documentation of instructions or completed activities.
  • Basic understanding of validation methodology such as IQ/OQ/PQ and the concept of risk management.
  • 5+ years of engineering experience in a manufacturing environment
  • Intermediate knowledge of Lean methodologies
  • Green belt in Six Sigma
  • Intermediate APQP/FMEA/PPAP knowledge
  • Excellent statistical/analytical skills for problem-solving with the ability to teach/coach others

Nice to have:

  • Proficient in statistical/analytical skills for problem-solving and able to teach/coach others
  • Basic understanding of Continuous Improvement (CI) methodologies and tools such as Six Sigma, Gauge R&Rs, etc.
  • Fundamental experience with PFMEA's and Risk Management

Travel required: 10%

What​ ​you​ ​will​ ​be​ ​part​ ​of:

  • Company Overview -
  • Our Culture and Values -
  • Our Sustainability "3D Printing a Better Tomorrow" -
  • Our Locations -
  • Check out our Video -

Additional Information:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Stratasys will provide reasonable accommodations for qualified individuals with disabilities. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Stratasys is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to their protected Veteran or disabled status and will not be discriminated against for their race, color, religion, sex, age, disability, military status, or national origin or any other characteristic protected under federal, state, or applicable local law. Please view Equal Employment Opportunity Posters provided by OFCCP here.

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