Sr Quality Engineer

Planet Pharma Group; Tempe (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

Planet Pharma in Tempe is seeking a Sr Quality Engineer to own the quality and compliance of process development and manufacturing of wafer-scale diabetes medical device products. You will partner with engineering and operations to drive Quality initiatives across Wafer & Sensor Operations and Hybrid Manufacturing.

The role emphasizes Design Controls, IQ, OQPQ, CAPA, risk assessment and change control, ensuring documentation meets regulatory requirements and supporting continuous improvement

Qualifications

• Bachelor’s degree in Engineering/Science with 4+ years of relevant experience, or Master’s with 2+ years, or PhD with 0.
• Diabetes wafer-scale medical device quality and compliance responsibilities at Tempe campus.
• Collaborates with engineering and operations to support Quality initiatives across Wafer & Sensor Operations.

Responsibilities

• Develops, modifies, applies and maintains quality standards and protocols.
• Ensures internal quality processes are compliant with governing standards.
• Collaborates with engineering and manufacturing to ensure quality standards are met.
• Implements inspection, testing and evaluation methods; conducts QA tests and statistical analysis.
• Performs CAPA investigations and change control; supports risk assessments.

Skills

Equipment Development, IQ, Process ^?

Regulatory/compliance review

Design Controls understanding

Education

Bachelor/Master/PhD in Engineering/Science or technical field

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).

What product line will this person support? Diabetes

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 the company’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 company 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.

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