Job description
Mantell Associates is currently partnered with a rapidly growing CDMO on their search for a Head of Quality for their Medical Device manufacturing facility located in California, who will be an integral member of the site leadership team. Do you have experience with In Vitro Diagnostic (IVD) Medical Devices Manufacturing?
Our client is one of the most reputable Life Science organisations on the planet, committed to discovering innovative and vibrant ways to advance global health - covering everything across Healthcare, Life Sciences and Electronics. You will get the opportunity to work with some of the brightest minds in the industry and join a diverse and inclusive business that offers you limitless career progression.
Head of Quality Key Responsibilities:
Responsible for all aspects of the site’s Quality organisation - Quality Assurance (QA), Quality Control (QC) and Quality Management System (QMS).
Provide leadership and strategy to ensure that all products/services are aligned with quality standards, regulations (FDA and other notified regulatory bodies) and customer/regulatory requirements.
Work closely with the Head of Operations to transform and create a site culture of compliance excellence - reporting to the top management on performances/improvements.
Ensure the site QMS is aligned with regulatory requirements (US FDA 820, MDSAP, IVDR etc.) and International Quality Standards (e.g. ISO 13485).
Work closely with the Manufacturing, Regulatory Affairs and other departments to make suggestions, set objectives and execute solutions for improvements in processes and compliance.
Oversee team members and ensure performance levels meet corporate, Quality and business objectives.
You will be the final site decision point for all Quality related topics.
Head of Quality Requirements:
Bachelor’s degree or higher in a scientific area
5+ years experience in leading Quality in a technical manufacturing environment
5+ years experience in management
Proven experience controlling Quality Management Systems (QMS) supporting ISO 9001, and ISO 13485 certifications, FDA Regulations (e.g. CFR820) in support of Medical Device class I-III products and EU IVDR regulations
CQE, CQA, CQPA, CBA, CMO/OE certifications are ideal.
Mantell Associates is a specialist Pharmaceutical and Life Sciences Headhunting firm. For more information on this role, please contact Onur Dilek on +44 (0)2038547700 or onur.dilek@mantellassociates.com
