Director, Device Quality Assurance

Title: Director, Device Quality Assurance
Reports To: Head of Quality & Compliance
Location: Redwood City, California
Classification: Exempt
Overview

Coherus BioSciences is seeking a highly motivated and experienced Device Quality Assurance professional 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.

Responsibilities:

• Contributes to the completion of specific programs and projects
• Guide risk management activities (Risk Management Plan, Risk Analyses, Risk Management Reports including post-production monitoring) in accordance with ISO 14971 and TIR 105
• Design History File support
• Assist/conduct Failure Investigations and problem solving sessions for non-conforming product
• Design Inputs
• Design Verification plans, protocols, and reports
• Designs and performs development working independently within defined parameters with minimal supervision required
• Liaise with Manufacturing Plants and device suppliers including product transfer/design transfer activities for new products.
• Design Reviews
• Function as a Quality Representative on Design/Development and Manufacturing project teams.
• Ability to communicate ideas and knowledge effectively and clearly to other individuals, teams and customers.
• Design Validation, including human factor/usability engineering
• Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
• Demonstrate excellent interpersonal communication skills, which enable you work with multiple BD business units.
• 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
• Design Outputs
• Consistent application of technical principles, theories, concepts and quality sciences / tools
• Provide Quality Assurance engineering support to all assigned projects, manufacturing facilities and suppliers.
• Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers
• May provide guidance and work direction to other team members
• Independently determines and develops compliant approach to solutions

Education and Skills:

• Thorough understanding of Statistical Methods for Quality Assurance including Measurement System Analysis (MSA)
• 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)
• 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)
• Ability to handle multiple projects simultaneously independently
• Thorough of design control principles and risk management (FMEA and Hazard Analyses)
• Excellent problem solving and analytical skills
• Good written and oral communication skills
• Experience in supplier management and relations, including quality agreement generation and maintenance

The Base Salary Range for this position is $185,000 - $230,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.