Senior Engineer - Aditi Consulting
Thousand Oaks, CA
About the Job
Day to Day Responsibilities:
Requirements:
Top 3 Must Have Skill Sets:
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
#AditiConsulting
- 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 company 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.
Requirements:
- 5+ years of experience pharma, biotech, medical device (open to different backgrounds but this is preferred)
- Bachelors Degree in Engineering or similar
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
Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).
Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.
#AditiConsulting
Source : Aditi Consulting
