INACTIVE
Full-Time
Director – Device Quality Assurance
Biologic platform therapeutics manufacturer
Biotechnology
$185,000 - $230,000
Senior, Expert
San Carlos, CA, USA
Required Skills
Communications
Management
Requirements
- 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
Responsibilities
- Provide Quality Assurance 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
Coherus' mission is to expand patient access to important, cost-effective medicines and deliver significant savings to the U.S. healthcare system. The company has created the leading biologics platform company solely focused on delivering high-quality biosimilar therapeutics that will expand patient access to life-changing medicines in regulated markets worldwide.
Company Stage
N/A
Total Funding
$1.2B
Headquarters
Redwood City, California
Founded
2010
Growth & Insights
Headcount
6 month growth
↓ -5%1 year growth
↓ -5%2 year growth
↓ -5%Benefits
Competitive base salary
Target bonus based on performance
stock options
Medical, dental, & vision coverage
PTO
401(k) plan
FSA
INACTIVE