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Senior/Principal Quality Engineer
Device/Combination Products
Confirmed live in the last 24 hours
Locations
Menlo Park, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Requirements
  • 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
  • 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
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
  • Design Reviews
  • Design Verification plans, protocols, and reports
  • Design Outputs
  • Design Inputs
Coherus BioSciences

201-500 employees

Biologic platform therapeutics manufacturer
Benefits
  • Competitive base salary
  • Target bonus based on performance
  • stock options
  • Medical, dental, & vision coverage
  • PTO
  • 401(k) plan
  • FSA
Company Core Values
  • Performance driven, results oriented to deliver organizational value
  • Team focused
  • Willingness to take risk, responsibility and demonstrate initiative
  • Balanced and thoughtful decision-making