Quality Engineer Ii

As a Quality Engineer II, you will be a key member of the Quality Assurance team and be 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 a hands-on and can-do attitude, embrace new challenges, enjoy collaborative efforts and peer coaching, have proven expertise in making improvements to manufacturing processes and also maintaining and improving Quality System processes.

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).

Additional Details:
Cytovale has a mandatory COVID-19 vaccination policy.
This position will be based in the San Francisco Bay area in a hybrid work environment.
Ability to work in the United States.