Job Title: Sr Quality Engineer
Job ID: 28885
Location: Tempe Arizona 85281
Duration: 12 months
Job Description:
Top 3 technical skills that are required for the role:
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 Baccalaureate 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 (see Education required above).
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, 40hrs/wk.
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? On-site M-F.
What is your timeline for scheduling interviews? As soon as possible.
What is your targeted timeline to get the person started? As soon as possible. This is a backfill role (previous contactor hired on to MDT) and need the continued support ASAP for the Unity Diabetes program.
What product line will this person support? Unity (Diabetes Operating Unit).
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.
Our Global Quality Strategy is rooted in the Client Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.
A Day in the Life
Responsibilities may include the following and other duties may be assigned
· 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.
TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, 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 R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
DIFFERENTIATING FACTORS
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 processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.
Required Knowledge and Experience: Requires a Baccalaureate 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.