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Crystal Equation
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Engineer Senior
Top 3 Must Have Skill Sets:
Red Flags:
Summary:
As a member of our 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.
This person ensures that Quality Systems identified for combination products are appropriate and compliant for commercial activities. Manages low to moderate complexity programs with minimal supervision.
Participates in technical aspects of problem-solving, complaints, and other investigations in relevant design control phases. Participates 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.
Responsibilities:
Basic Qualifications:
OR
OR
OR
OR
Pay range is $34 - $39 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.
Engineer Senior
1 Amgen Center Dr. Thousand Oaks, CA 91320 US
Posted: 10/30/2024
2024-10-30
2024-12-01
Job Number: 39884
Job Description
Engineer Senior
Top 3 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
Red Flags:
- Lack of combination product experience
- Poor communication skills
- No experience in quality roles
Summary:
As a member of our 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.
This person ensures that Quality Systems identified for combination products are appropriate and compliant for commercial activities. Manages low to moderate complexity programs with minimal supervision.
Participates in technical aspects of problem-solving, complaints, and other investigations in relevant design control phases. Participates 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.
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 our 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
Pay range is $34 - $39 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.
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