Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 201222
The Quality Systems Engineer will ensure overall Quality Management System (QMS) compliance to internal process/procedures as well as regulatory requirements/standards and ensure understanding of applicable laws and regulations so that the company’s risks are identified and managed appropriately. S/He will use Quality System Engineering principles, tools and techniques to develop, optimize, and support systems and processes that are aligned with the overall Company strategy and mission affecting continuous process improvement. To provide solutions and processes that support scalability and compliance to domestic and international regulatory requirements.
Roles and Responsibilities:
- Work together with strategic partners across global sites to assure compliance with all company procedures and regulatory requirements.
- Lead Quality System projects to support new and changing regulatory requirements
- Create, approve, and maintain company quality documents, such as quality manual, quality procedures, work instructions, and forms
- Support CAPA program as a CAPA owner or CAPA Team member
- Participate in internal or external audits or regulatory inspections across global sites
- Complete gap assessment for regulations, regulatory standards, and corporate procedures
- Train company employees on Quality System Regulations and quality system foundational principles
- May participate in IT projects to support computer software validation requirements
- Provide data to support; process analysis, process controls, FDA trending and finding history, and needed process improvements activities
- Support, consult, train ,and lead quality improvement projects
- Provide Quality System Consultation
- Support regulatory finding responses
- Lead new site integration activities across global sites
- Assist in the development of Quality System Metrics and KPIs
- Bachelor of Science degree in Technical, Engineering or Science related field.
- Minimum 5 years’ of experience as a Quality Engineer
- Strong knowledge of ISO 13485 :2016; Medical Device Single Audit, and 820 requirements
- Minimum 7ears’ experience in quality in the medical device or pharmaceutical industry
- Previous experience participating in notified body and FDA inspections
- 2+ years of FDA /ISO 13485 lead auditing experience
- Experience using statistical techniques applications
- Experience with electronic quality systems applications like Trackwise, Agile, Windchill, Master Control
- Familiarity with EU-MDR, MDSAP, Health Canada, and other international regulatory requirements
- Familiarity with GMPs related to Combination and Drug Products
- Prefer previous software quality engineering and validation experience
- Ability to work on virtual teams, remote management; self-directed
- Prefer ASQ CQA, CQE
- Ability to be a team player and a partner to the cross- functions teams; be part of the solution and demonstrate ability to use risk-based judgment.
- Critical thinking skills and a passion to work in a fast-paced industry with complex/cutting edge technology
- Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.