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).