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Quality Assurance Specialist

2 months ago

Eden Prairie, Minnesota, United States Stratasys Full time

Quality Assurance Specialist

Location: Eden Prairie, MN, US

Job ID: 53740

Category: Manufacturing & Operations

About Stratasys:

Stratasys stands at the forefront of 3D printing technology, driving the global transition to additive manufacturing. Our innovative solutions cater to diverse sectors including aerospace, automotive, consumer goods, and healthcare. By leveraging advanced 3D printers, polymer materials, a comprehensive software ecosystem, and on-demand parts, we empower leading organizations to enhance product design, streamline manufacturing processes, and elevate patient care.

Role Overview:

The Quality Assurance Specialist will deliver continuous quality support to manufacturing operations, aiming to mitigate product variability that could impact customer satisfaction. This role encompasses supplier quality management, new product introduction (NPI), and Continuous Improvement (CI) initiatives for both products and processes.

Key Responsibilities:

  • Compliance Management: Act as the primary liaison among operations, suppliers, and customers, ensuring adherence to specifications, quality standards, and regulatory requirements for manufactured products. Communicate significant quality issues and risks identified during quality assessments.
  • Non-Conformance Resolution: Collaborate with engineering and production teams to investigate and address quality and compliance challenges. Utilize data and problem-solving methodologies to implement corrective actions (RCCA).
  • Corrective and Preventative Actions (CAPA): Lead or participate in teams focused on resolving production, customer, and supplier issues, including non-conformances, CAPA activities, and audit findings.
  • Supplier Quality Assurance: Assist in the investigation and resolution of supplier-related issues. Support activities such as evaluations, First Article Inspections (FAI), material sourcing, and qualifications. Participate in supplier audits and reviews.
  • Testing and Inspection: Develop and implement protocols for inspecting and testing in-process raw materials and finished products. Address defects or failures and collaborate with the Lab Inspection & Test team to explore improvement opportunities.
  • Data Analysis: Leverage data to identify root causes and prioritize enhancements in the inspection of finished products, in-process materials, and bulk raw materials, recommending corrective actions as necessary.
  • Documentation and Reporting: Evaluate and analyze efforts in organizing, documenting, and interpreting inspection support documents and records.

Continuation Engineering:

  • Contribute to projects by providing insights for process improvements and assisting in the development of tactical strategies to implement team objectives.
  • Support validation and qualification activities.
  • Review and update Standard Operating Procedures (SOPs).

Qualifications:

  • Bachelor's degree in Engineering or a related field, or equivalent experience.
  • Minimum of 2 years of experience in Quality Engineering.
  • Familiarity with material properties and processing, particularly in polymers.
  • Experience in a regulated environment and knowledge of ISO9001 standards.
  • Proficient in conducting and facilitating Root Cause Analysis (RCA) and CAPA activities.
  • Basic understanding of Statistical Process Control (SPC) and statistical analysis.
  • Ability to create and update documentation of processes and completed activities.
  • Understanding of validation methodologies such as IQ/OQ/PQ and risk management concepts.
  • 5+ years of engineering experience in a manufacturing context.
  • Intermediate knowledge of Lean methodologies.
  • Green Belt certification in Six Sigma.
  • Intermediate knowledge of APQP, FMEA, and PPAP processes.
  • Strong statistical and analytical skills for problem-solving, with the ability to mentor others.

Preferred Qualifications:

  • Proficient in statistical and analytical problem-solving skills, with the capability to mentor others.
  • Basic understanding of Continuous Improvement (CI) methodologies and tools such as Six Sigma and Gauge R&Rs.
  • Fundamental experience with PFMEA and Risk Management.

Travel Requirements: 10%

Company Culture: Stratasys is committed to fostering an inclusive environment where all individuals are treated with respect and dignity. We are an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, or national origin.