Sr Quality Engineer - Exempt

Lancesoft; Tempe (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

Lancesoft in Tempe, AZ is seeking a Quality Engineer focused on development and manufacturing of wafer-scale diabetes medical device products. You will work with engineering and operations to support Quality initiatives and ensure compliance with applicable regulatory requirements.

Candidate should have a strong background in IQ, process characterization, OQPQ, validation, and the ability to review documentation for compliance across internal procedures and regulatory standards.

Qualifications

• Must have strong statistical analysis techniques and 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 communication skills, both technical writing and presentation, with experience in presentations.

Responsibilities

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into finished products.
• Ensure internal quality processes, procedures, and systems comply with governing standards.
• Collaborate with engineering and manufacturing to meet quality standards.
• Design or specify inspection/testing mechanisms; conduct quality assurance tests; perform statistical analysis to assess cost and responsibility for nonconforming products.
• Support and drive CAPA investigations and effectiveness verification testing.
• Lead and/or support investigations of non-conforming product and coordinate cross-functional teams.

Job description

Job Opportunity in Tempe, AZ

Join our team in Tempe, AZ, and contribute to the development and manufacturing of wafer scale Diabetes medical device related products. As a key player in our operations, you will work closely with engineering and operations functions to support essential Quality initiatives.

Must Have Qualifications

• 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 Have Qualifications

• 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

Top 3 Technical Skills Required

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

Education and Experience

Requires a Baccalaureate degree in Engineering, Science, or technical field and a minimum of 4 years of relevant experience in Engineering and/or Quality OR a Master's degree in Engineering, Science, or technical field with a minimum of 2 years relevant experience OR a PhD in Engineering, Science, or technical field with 0 years relevant experience.

Job Responsibilities

Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished materials product. Ensure internal quality processes, procedures, and systems are compliant with all governing standards. Collaborate with engineering and manufacturing functions to ensure quality standards are met. Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Design or specify inspection and testing mechanisms and equipment;conduct quality assurance tests;and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Work 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. Support 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. Use knowledge of statistics on acceptance criteria, DOE, and comparison testing to support manufacturing engineers in the development of compliant test plans and reports. Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. Support risk assessment processes for manufacturing and development including process FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements. Develop and support 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. Support 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. Support and drive proper change control procedures and collaborate with change owners on their implementation strategies and change documentation. Facilitate group meetings and project leadership that drives comprehensive technical solutions in your quality domain. Communicate 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.