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Senior Quality Engineer, Drug Delivery Devices – fully remote (JP13309)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Senior Quality Engineer, Drug Delivery Devices – fully remote (JP13309)
Location: Thousand Oaks, CA. 91320 (fully remote)
Business Unit: Final Product Technologies Commercial-Mechanical
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $43 - $46/hour W2
Posting Date: 10/30/2024.
Notes: Only qualified candidates need apply. Fully remote (preferably local to Thousand Oaks, CA. but not required).
Standard business hours (8 AM -5 PM).
3 Key Consulting is hiring! We are recruiting a Senior Quality Engineer, Drug Delivery Devices for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
As a member of our client's Commercial Quality group for drug delivery systems, the Sr Quality Engineer – Commercial Quality will provide quality engineering support for the product life cycle management and design control systems in the maintenance of commercialized drug delivery devices, combination products, and non-combination products.
Responsibilities include:
Top Must Have Skill Sets:
Day to Day Responsibilities:
Basic Qualifications:
Red Flags:
Interview Process:
Phone interviews, two rounds
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Location: Thousand Oaks, CA. 91320 (fully remote)
Business Unit: Final Product Technologies Commercial-Mechanical
Employment Type: Contract
Duration: 1+ year with likely extensions and/or conversion to a permanent position.
Rate: $43 - $46/hour W2
Posting Date: 10/30/2024.
Notes: Only qualified candidates need apply. Fully remote (preferably local to Thousand Oaks, CA. but not required).
Standard business hours (8 AM -5 PM).
3 Key Consulting is hiring! We are recruiting a Senior Quality Engineer, Drug Delivery Devices for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
As a member of our client's Commercial Quality group for drug delivery systems, the Sr Quality Engineer – Commercial Quality will provide quality engineering support for the product life cycle management and design control systems in the maintenance of commercialized drug delivery devices, combination products, and non-combination products.
Responsibilities include:
- Participation in the implementation of Design controls per FDA CFR 820.30.
- Corrective and Preventive action projects
- Documentation related to investigation of product complaints, trending of quality data, and other assignments as given.
- Ensures that Quality Systems identified for combination products are appropriate and compliant for commercial activities. Manages low to moderate complexity programs with minimal supervision.
- Participate in technical aspects of problem-solving, complaints, and other investigations in relevant design control phases.
- Participate in non-design control investigations on an as needed basis.
- This position reports to the Sr Manager Quality Engineering, CPOQ Commercial and is a liaison with CPOQ Development.
Top Must Have Skill Sets:
- Deep understanding of quality processes including change control, design controls, risk assessment and management, and root cause analysis.
- Combination product knowledge and understanding including functional knowledge of applicable guidance, regulations and standards to enable future compliance as projects enter design controls
- Knowledge of quality engineering and device engineering
- Person needs to be very thorough and very detail oriented
- 5+ years of experience pharma, biotech, medical device (open to different backgrounds but this is preferred)
- Bachelors Degree in Engineering or similar
Day to Day Responsibilities:
- Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for combination and non-combination products associated with Combination Product Operations activities.
- Attend development program meetings as required as part of program working teams. Work cross-functionally with individuals and project teams to ensure success of development project efforts. Provide guidance on documentation structures created during development activities. Responsible for identifying proper GMP or Non-GMP phase-appropriate documentation strategies and repositories required for the design and development process to ensure compliance with applicable regulations and client Procedures.
- Provide input on device configuration specifications, Maintain the Design Traceability Matrix, and provide review and approval for subordinate project plans and associated projects.
- Provide Quality oversight of Design Characterization and Verification and Validation activities associated with lifecycle management programs. Ensure adherence to all relevant regulations and standards.
- Represent CPOQ Commercial Quality and participate in onsite supplier technical support visits, as needed.
- Contribute to content and review of regulatory submissions and responses to agency inquiries. Participates in audits and inspections.
- Scope includes a wide range of medical devices (including prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, software as medical devices and on-body injector systems), combination products, and non-combination products. Responsible for upkeep and evaluation of Control Plans and review of Human Factors Engineering (HFE) Protocols and Reports.
Basic Qualifications:
- Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Red Flags:
- Lack of combination product experience
- Poor communication skills
- No experience in quality roles
Interview Process:
Phone interviews, two rounds
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards,
3KC Talent Acquisition Team