Senior Quality Engineer

Job Details

Job Title:
Sr Quality Engineer – Medical Device

Job Location:
Tempe, Arizona (Fully onsite)

Type: W2 contract

Job Start Date - 1/26/26

Job End Date - 5/29/26

In this Sr Quality Engineer for Operations Quality, you will have responsibility for the Quality and Compliance of process development and manufacturing of implantable electronic products.

Responsibilities may include the following and other duties may be assigned.

• Ensure that internal quality processes, procedures and systems are compliant to all governing standards.
• Support manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process 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.
• Support risk assessment processes for manufacturing and development including process FMEA and design FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements.
• 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

• Strong understanding of operations/manufacturing processes and products;
  Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics
• Ability to work independently and provide comprehensive feedback on complex issues; support risk assessment processes for manufacturing and development
• Strong Communication Skills (verbal and written).

Education Required: Bachelor’s degree, Years’ Experience

Required:

4+ years’ work experience

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place. 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.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. 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.

SPECIALISTCAREER STREAM: Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact:
May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity:
Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of…