Director, Quality Engineering (Device/Combination Products)

Title:                                   Director, Quality Engineering (Device/Combination Products) Reports To:                         Head of Quality & ComplianceLocation:                             Redwood City, CaliforniaClassification:                     Exempt  Overview
Coherus BioSciences is seeking a highly motivated and experienced Device Quality Engineer to provide technical leadership and Quality oversight to Coherus’ device and combination product development project and commercial manufacturing activities.  This position plays an integral role working with cross functional team members and contract organizations to define and execute the device strategies for all assigned programs.  This individual will also be responsible for ensuring all Design Control elements are satisfied and fully compliant with applicable regulations. This position reports directly to the Head of Quality and Compliance. 

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, including human factor/usability engineering
Design Reviews
Design Verification plans, protocols, and reports
Design Outputs
Design Inputs

Guide risk management activities (Risk Management Plan, Risk Analyses, Risk Management Reports including post-production monitoring) in accordance with ISO 14971 and TIR 105
Liaise with Manufacturing Plants and device suppliers including product transfer/design transfer activities for new products.
Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
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
Contributes to the completion of specific programs and projects
Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers
Ability to communicate ideas and knowledge effectively and clearly to other individuals, teams and customers.
Independently determines and develops compliant approach to solutions
May provide guidance and work direction to other team members
Designs and performs development working independently within defined parameters with minimal supervision required

Education and Skills:

Bachelor Degree Science or related field (Biomedical/Mechanical engineering preferred)
ASQ Certified Quality Engineering and/or Certified Six Sigma Blackbelt (CQE or CSSBB) preferred
Quality Engineering experience or 12+ years industry experience (Healthcare/ Pharmaceutical)
Thorough understanding of industry regulations: QSR/cGMP and ISO/ICH standards (21CFR820, ISO 14971, ICH Q9, ISO 10993, ISO 11608, IEC 62366, 21CFR Part 4)
Thorough of design control principles and risk management (FMEA and Hazard Analyses)
Thorough understanding of Statistical Methods for Quality Assurance including Measurement System Analysis (MSA)
Experience in supplier management and relations, including quality agreement generation and maintenance
Good written and oral communication skills
Excellent problem solving and analytical skills
Ability to handle multiple projects simultaneously independently

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. 

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