Overview As a Quality Engineer I, you support new product development and ongoing product line quality through Quality Engineering and Quality Assurance practices. You will ensure compliance with regulations across receipt, storage, manufacturing, and distribution. You'll collaborate with R&D and cross-functional teams to enable safe, effective product releases and resolve quality issues.
Compensation / Benefits- Comprehensive Medical, Dental, and Vision
- Life Insurance
- Supplemental Benefits
- 401(k) with Traditional and Roth options
- Employee Stock Purchase Plan (ESPP)
- 10 Paid Company Holidays
Responsibilities- Provide QE project support for NPD and transfer to manufacturing
- Offer QE technical support to resolve quality issues
- Analyze non-conformances and implement CAPA plans
- Prepare, execute, and analyze validations for equipment, processes, and software
- Collect and analyze data to support validations and studies
- Develop qualifications/ validations to ensure reliable, safe, and effective products prior to release
- Partner with R&D and cross-functional groups for development and launch, apply design controls and risk management
- Manage sampling plans and assess manufacturing risk and acceptance sampling
- Develop risk management documents including FMEA
- Review/approve/validate Test Methods
- Interface with manufacturing facilities as required
- Conduct investigations, bounding, documentation, and review of non-conformances, CAPA, and customer complaints
- Other responsibilities as assigned
Key requirements- Bachelor's Degree in engineering or equivalent experience
- 0-2 years experience in FDA-regulatory industry (pharma/biomedical/medical device) with knowledge of GMP, QSR, and ISO standards
- cross-functional collaboration
- problem-solving
- attention to detail
- Quality Engineering
- CAPA
- FMEA
