Title: Senior/Principal Quality Engineer (Device/Combination Products)
Reports To: Director, Quality Engineering
Location: Redwood City, California
The Senior/Principal Quality Engineer is responsible for ensuring combination products are developed in accordance with Coherus SOPs and appropriate device regulations. This role supports the design and development of combination products up until product transfer to manufacturing. This role contribute significantly to risk management activities and statistical analysis.
- Provide Quality engineering support to all assigned projects, manufacturing facilities and suppliers.
- Function as a Quality Representative on Design/Development and Manufacturing project teams.
- Ensure Design Control Elements are satisfied:
- Design History File support
- Design Validation
- Design Reviews
- Design Verification plans, protocols, and reports
- Design Outputs
- Design Inputs
- Assist/conduct Failure Investigations and problem solving sessions for non-conforming product
- Demonstrate excellent interpersonal communication skills, which enable you work with multiple BD business units.
- Consistent application of technical principles, theories, concepts and quality sciences / tools
- Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
- Contributes to the completion of specific programs and projects
- Provides guidance and support for design verification, design validation, test method validation activities and risk management activities.
- Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers
- Ability to effectively and clearly communicate ideas and knowledge to other individuals, teams and customers.
- Independently determines and develops approach to solution
- May provide guidance and work direction to other team members
- Designs and performs development working independently within defined parameters with minimal supervision required
- Liaise with Manufacturing Plants
- Provide functional support to cross-functional teams Qualifications
Education and Skills:
- Bachelor Degree Science or related field
- Quality Engineering experience 7+ years industry experience (Healthcare/ Pharmaceutical)
- Thorough understanding of industry regulations: QSR/cGMP, ISO QM standards (21CFR820, ISO14971, IEC62304, 21CFR Part 4)
- Knowledge of design control principles
- Thorough understanding of Statistical Methods for Quality Assurance
- Good written and oral communication skills
- Excellent problem solving and analytical skills
- Ability to handle multiple projects simultaneously in an unsupervised environment.
Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.