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Principal Quality Engineer - Development Quality

Thousand Oaks, CA 91362

Posted: 07/02/2024 Employment Type: Contract Job Category: Quality Job Number: 3878

Job Description

In this vital role you will be accountable for advice to, and oversight of, technical aspects in design control, and design and technical transfers. In addition, this role will be a single Quality point of contact for device design and related issues in development of devices and combination and non-combination products. Accountable for ensuring that Quality Systems for design and development of devices and combination products are appropriate and compliant for pre-commercial development activities. Independently manages high complexity programs with greater risk to the business including those which are novel or new to the company, including electromechanical, and/or internally developed. Responsible to represent CPOQ Development in external engagements. Provides guidance of proper quality resource balancing on project(s) as required, ensuring CPOQ resources are proactively managed. Reviews and approves Design History File (DHF) content and user documentation and assessments throughout the design & development lifecycle, including content from suppliers and partners. Participates in definition and development of final product requirements, in particular for specialized products. Approves device components and final product or the device constituent of a combination product specification as part of development program.

Responsibilities:
  • Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for combination and non-combination products associated with Final Product Technologies activities.
  • Attend development program meetings as required as part of program working teams.
  • Work multi-functionally with individuals and project teams to ensure success of development project efforts.
  • Provide guidance on documentation structures created during development activities.
  • Identify proper GMP or Non-GMP phase-appropriate documentation strategies and repositories required for the design and development process to ensure compliance with applicable laws and company Procedures.
  • Provide feedback to the Design and Development Plans for projects, and review and approve relevant combination product Design Control documentation including (Design Input Documents, Risk Summary Reports, Verification Plans, Characterization Protocols and Reports, Design Validation/Qualification Protocols and Reports, Design Specifications, Trace Matrices, Design and Tech Transfer Plans, PLAN Specifications (Development), PCS device configuration specifications (qualified), PLAN component specifications (developmental), PCS component specifications (qualified), Create the Design Traceability Matrix, and provided review and approval for subordinate project plans and associated projects.
  • Actively participate and contribute to applicable Technical Reviews and Design Control Phase Design Reviews.
  • Provide Quality oversight of Design Characterization and Verification and Validation activities.
  • Ensure alignment to all relevant regulations and standards based on the type of device under development.
  • Represent CPOQ Development Quality and participate in onsite supplier due diligence visits, as needed, in support of supplier qualification and development as it relates to design control activities.
  • Contribute to content and review of regulatory submissions and RTQs by collaborating to develop complete formal written responses. Participates in audits and inspections, is well prepared by owning relevant details that are supported by evidence and for associated projects.
  • Scope may include a wide range of devices, including but not limited to prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and on-body injector systems.
  • Development projects may include primary container, mechanical, electrical, and/or software as part of the system(s).
  • Responsible for ensuring program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers.

Basic Qualifications:
  • Doctorate degree and 2 years of Quality experience
Or
  • Master’s degree and 4 years of Quality experience
Or
  • Bachelor’s degree and 6 years of Quality experience
Or
  • Associate’s degree and 10 years of Quality experience
Or
  • High school diploma / GED and 12 years of Quality experience

Preferred Qualifications:
  • 7+ years of quality and manufacturing experience in biotech or pharmaceutical industry
  • Bachelor's degree in a Science field
  • Deep and broad understanding of quality processes including change control, design controls, risk assessment and management, and root cause analysis.
  • Deep combination product expertise and experience including functional knowledge of applicable guidance, regulations and standards to enable future compliance as projects enter into design controls
  • Strong knowledge of quality engineering and device engineering
  • Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics
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About Thousand Oaks, CA

Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.