Quality Engineer
CytoVale
This job is no longer accepting applications
See open jobs at CytoVale.See open jobs similar to "Quality Engineer" Breakout Ventures.Quality Assurance
San Francisco, CA, USA
Posted on Friday, February 2, 2024
Primary Responsibilities:
- Monitor manufacturing process performance quality indicators, carry out supporting analysis / investigations and drive actions / improvements as needed.
- Monitor product field performance quality indicators, carry out supporting analysis / investigations, and drive actions / improvements as needed.
- Support Quality Management System processes and ensure any Quality issues are investigated and resolved.
- Drive Quality Management System continuous improvement. Identify opportunities to maximize efficiency and ensure/promote compliance with company personnel.
- Evaluate proposed product 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.
- Work collaboratively with Cytovale Operations and Contract Manufacturing Organizations to:
- Assist in developing process validation protocols (IQ/OQ/PQ); review and approve validation reports as needed.
- Assist in developing process FMEA or equivalent production risk assessments.
- Evaluate and analyze current manufacturing processes to ensure necessary process controls in place.
- Identify potential manufacturing process improvements that will lead to better quality products and improve yields.
- Develop and validate new equipment, tools, test methods, and fixtures.
- Support internal, supplier and 3rd party audits.
- Provide support to the Engineering and Operations teams with guidance related to quality processes.
Minimum Qualifications:
- Bachelor’s degree in scientific discipline (e.g. Engineering, Biology, or Medical Devices, 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.
- Candidate should be able to prioritize tasks, drive process improvements, demonstrate the ability to think critically and thrive in a fast-paced environment.
Preferred Qualifications:
- IVD experience
- Knowledge/experience with microfluidics and plastic injection molding
- Prior experience with an electronic Quality Management System (eQMS).
This job is no longer accepting applications
See open jobs at CytoVale.See open jobs similar to "Quality Engineer" Breakout Ventures.