Quality Engineer II
3 months ago
As a Quality Engineer II, you will be a key member of the Quality Assurance team and responsible for supporting process and product performance quality indicators, quality management system effectiveness, design transfer and process validation activities with our CMOs, and manufacturing process improvements. Successful candidates will work well in a fast-paced startup environment, can balance priorities, demonstrate the ability to think critically, have a “can-do” attitude, and value cross-functional collaboration and continuous improvement.
Responsibilities:
- Interface with cross-functional partners on new product development and design/process change control. Evaluate proposed changes for qualification and validation requirements and assist in change implementation.
- Support the Design Transfer team in ensuring the product design is successfully translated into production specifications and processes.
- Act as primary quality contact with contract manufacturers, working with them to solve issues and recommend improvements.
- Contribute to Risk Management activities, including but not limited to risk assessment, DFMEA, PFMEA.
- Assist in maintenance of Design History File (DHF), and Device Master Record (DMR).
- Work collaboratively with Cytovale Operations and Contract Manufacturing Organizations to:
○ Monitor quality performance metrics and drive resulting corrective/preventive actions.
○ Support process validation (IQ/OQ/PQ); review and approve validation reports.
○ Evaluate manufacturing processes to ensure necessary process controls are in place and
identify potential improvements.
○ Support development of new equipment, tools, test methods, and fixtures. - Monitor product field performance quality indicators, carry out supporting analysis / investigations, and drive actions/improvements as needed.
- Support internal, supplier and 3rd party audits.
- Drive Quality Management System continuous improvement. Identify opportunities to maximize efficiency and ensure/promote compliance with company personnel.
Qualifications:
- Bachelor’s degree in scientific discipline (e.g. Engineering, Life Sciences, etc).
- 3+ years related experience in the medical device industry.
- Proficiency with Microsoft Office (e.g., Word, Excel, Project, etc.)
- Knowledge of regulations and standards such as 21 CFR 820, ISO 13485, ISO 14971, etc.
- Prior experience with QMS processes such as Document Control, Materials Control, Receiving, CAPAs, NCRs, Training, etc. required.
- Candidate should have good organizational skills as well as strong written/verbal communications skills.
Requirements
- This is a hybrid position, based in the San Francisco Bay Area. Fully remote work available for exceptional candidates.
- Ability to work in the United States
- Up to 15% domestic travel
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