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- Extensive experience with PMA submissions for class 3 combination devices.
- Proven track record in navigating the dynamic landscape of startup environments.
- Demonstrated capability in assembling and leading a quality team from the ground up.
- Proficiency in working with Vascular Devices.
- Expertise in drug delivery.The VP Quality will:
- Drive the evolution of our Quality Management System (QMS) to meet global quality objectives and regulatory requirements.
- Lead core quality system activities to uphold compliance with international medical device regulations and certifications.
- Craft, refine, and uphold procedures, specifications, and standards for product quality control in adherence to ISO 13485, MDR, and 21 CFR 820.
- Ensure adherence to FDA, ISO, and industry-specific standards, maintaining impeccable regulatory compliance.
- Proactively identify and address quality risks, overseeing training, supplier management, and complaint processes.
- Establish and implement robust quality control processes, orchestrating investigations and corrective actions as necessary.
- Cultivate a high-performing quality team through strategic recruitment, comprehensive training, and ongoing mentorship.Compensation:
$220,000 - $250,000 annually
If you are having difficulty in applying or if you have any questions, please contact Ollie Archer at (+1) or
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
INDCQA
VP Quality - Mountain View, United States - Proclinical Staffing
Description
VP Quality - Permanent - Onsite
Proclinical Staffing is seeking a VP Quality to join a cutting-edge biotech company. This is a permanent role located in Mountain View, CA.
Skills & Requirements: