Interested in Joining Zelegent?
If your background fits one of the job descriptions lower on this page, and you are passionate about solving one of the most impactful healthcare problems today and improving people’s lives, you may be a good fit for Zelegent.
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Consulting Director, Quality
Hands-on responsibility for, and all-inclusive management of, the Quality function for a start-up Specification Developer/Medical Device Manufacturer of Record, including: developing and maintaining Quality Manual, Standard Operating Procedures, Supplier Quality auditing, Document Control, Complaint Handling, procurement of ISO 13485 Certification and State of CA Manufacturing License, and quality oversight of manufacturing lot release for a cleared Class II medical device.
- Minimum 10 years’ experience direct management of a medical device Quality System
- Excellent writing and organizational skills
- Experienced and direct interaction with FDA Office of Compliance and Notified Bodies
- Significant experience with Quality Systems and key regulated processes including: design controls, process validation, injection molding, medical device manufacturing processes, sterilization, and bio-safety testing of materials
- Proven success providing Quality Management consulting expertise to medical device clients
Must be an accountable, self-motivated, disciplined, and well-organized individual that is accustomed to maintaining excellent records, capable of working independently with the ability to make decisions and recommendations that directly affect corporate compliance and the Zelegent, Inc. Quality System.
PHYSICAL REQUIREMENTS / WORK ENVIRONMENT:
Position is 75% home-based/remote.
The qualified candidate should reside within approximately 60 miles (or an approximately 1-hour drive) of the Zelegent, Inc. Corporate Office in La Jolla, CA for management of on-site regulatory agency visits. Must also be available for travel to Approved Suppliers.
The position primarily works in a home office environment with a requirement of 25% presence in the corporate office. It requires frequent sitting, daily use of a computer, a reliable remote office internet connection, and other computing and digital functions e.g., video conferencing. Some local travel is necessary – the ability to operate a motor vehicle and maintain a valid Driver’s License is required and essential.
Reports directly to the VP, Regulatory and Clinical Affairs. Position has no direct reports. Interacts with Chief Executive Officer when present onsite at corporate office.
CONSULTING / QUALITY MANAGEMENT SERVICES FEE:
Negotiable based upon candidates’ relevant experience. This is a non-salaried Form 1099-MISC position. Equity options available.
The Consulting Director, Quality will provide compliance leadership in the specific areas of internal and external audits, analysis of quality data and Quality System improvements and maintenance, Management Review, and will ensure ongoing compliance with all applicable regulations and standards via continuous review of these systems. This position develops and coordinates plans to identify, address and mitigate potential risks to compliance in various processes implemented to support the Company’s activities. This position will coordinate and manage the Complaint Handling function and interaction with the Company’s strategic business and distribution partner.
- Conduct and document Design Reviews
- Coordinate and ensure proper follow up to external audits (e.g., FDA Inspections, Customer Audits and ISO audits)
- Coordinate field actions
- Coordinate and monitor Quality System metrics
Please no recruiters. Zelegent, Inc. is an equal opportunity employer.