Seeking a senior level Quality Engineer to support quality activities related to in vitro diagnostic (IVD) product development in accordance with FDA, ISO, CMDR and other IVD regulations.
location: Redwood City, California
job type: Permanent
salary: $130,000 - 160,000 per year
work hours: 9 to 5
- Provides design controls guidance/support for IVD projects in regards to User Requirements and Specification, System and Subsystem Requirements/Specifications, Design Verification and Validation, Test Method Validation, Risk Management, Design Transfer, Design Reviews and Product Lifecycle Management
- Leads all product Risk Management activities ensuring compliance with ISO 14971
- Ensures design changes are captured and follow the design change control process
- Provides Regulatory and International Standards guidance/support
- Provides guidance on stability testing, sample plan definition, and study development
- Manages and mentors junior quality engineers
- Ensures required documentation is completed prior to product transfers and worldwide product launches
- Provides guidance on cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities
- Supports processes such as document control, nonconformances, CAPAs, and developing Quality metrics
- Identifies opportunities for continual improvement and works with management and team members to successfully address these opportunities
- Performs and document internal audits and make recommendations for corrective actions
- Reports and documents all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable
- Perform related duties as assigned
- Bachelor's degree in Chemistry, Biology, Engineering or a related scientific discipline.
- Certified Qualified Engineer (CQE) preferred
- 5 years of recent experience in an in vitro diagnostic (IVD) or medical device company
- 5+ years of quality experience in an FDA/ISO regulated environment
- Working knowledge of (FDA21 CFR Part 820), ISO 13485, ISO 14971, IVDD, CLIA and CA requirements
- Knowledge of applying statistical analysis for testing, process control, and design of experiments
- Ability to work effectively within team and across functions
- Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
- Excellent problem-solving and analytic skills
- Effective communication and inter-personal skills
skills: Quality Assurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.