Senior Quality Engineer

Sr. Quality Engineer (12-month contract // Tempe, AZ):

Top 3 Required Skills:

1. Strong background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation
2. Critical documentation review with the ability to assess compliance to internal procedures and regulatory requirements using general quality principles, procedures and methodologies
3. Understanding of Design Controls and how requirements flow down to process development and validation

Education Required: Requires a Bachelor’s Degree in Engineering, Science or technical field and minimum of 4 years of relevant experience in Engineering and/or Quality OR Master's degree in Engineering, Science or technical field with a minimum of 2 years relevant experience OR PhD in Engineering, Science or technical field with 0 years relevant experience

Years’ Experience Required: 2-4yrs minimum depending on degree

Description:

In this exciting role as a Sr Quality Engineer, you will have responsibility for the Quality and Compliance of process development and manufacturing of wafer scale Diabetes medical device related products at client’s Tempe Campus. Role includes providing a strong partnership with engineering and operations functions to support key Quality initiatives across campus in Tempe's Wafer & Sensor Operations (WSO) and/or Hybrid Manufacturing Operations areas.

Duties:

• Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Ensures internal quality processes, procedures and systems are compliant to all governing standards.
• Collaborates with engineering and manufacturing functions to ensure quality standards are met.
• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Works with the customer and local Design teams to ensure appropriate Design Outputs have been provided to the manufacturing team that enable high product quality via Process and Test Method Validations.
• Supports manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Development (characterization), OQPQ and Test Method Development and Validation.
• Uses knowledge of statistics on acceptance criteria, DOE, and comparison testing to support manufacturing engineers in the development of compliant test plans and reports.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Supports risk assessment processes for manufacturing and development including process FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements.
• Develops and supports solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards, issue reporting, and other performance measures.
• Supports CAPA investigations, improvements, and effectiveness verification testing.
• Lead and/or support investigations of non-conforming product, materials, or processes through the coordination of cross functional teams while simultaneously performing the role of Quality Engineer.
• Responsible for documentation of the non-conformances, identification of population, containment of population, and communication of non-conformance to applicable parties.
• Supports and drives proper change control procedures and collaborates with change owners on their implementation strategies and change documentation.
• Facilitates group meetings and project leadership that drives comprehensive technical solutions in your quality domain.
• Communicates clearly regarding technical issues and solutions.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Must Haves:

• Applied use of statistical analysis techniques & DOE design and execution
• Experience with general quality principles, procedures, and methodologies
• Proficiency in Microsoft Office Applications (Word, Excel, PowerPoint, Teams)
• Strong background in Equipment Development, IQ, Process Characterization, OQPQ, and Test Method Development and Validation
• Strong overall communication, both in technical writing and presentation skills, as well as experience with presentation tools and applications
• Understanding of regulatory requirements (e.g. 21CFR820, ISO 13485, FDA-GMP, etc.)

Nice to Haves:

• 4 years of engineering experience in a medical device manufacturing environment
• 4 years of Process Quality or Process Engineering experience
• DRM or DFSS certification
• Experience with electronics manufacturing including wafer fabs and microelectronics assembly (SMT and/or chip and wire)
• Experience with internal and external audits including FDA, MDSAP and/or TUV
• Strong understanding of medical device manufacturing processes and products