Director, Quality Engineering (Device/Combination Products)

Title: Director, Quality Engineering (Device/Combination Products)
Reports To: Head of Quality & Compliance
Location: Redwood City, California
Classification: 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.

Responsibilities:

• 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

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.

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.