Ichor Medical Systems, Inc.
6310 Nancy Ridge Dr. Ste 107, San Diego, CA 92121
Quality Manager/Senior Manager/Group Leader
General Job Description:
This is a hands-on leadership role for the ongoing development, implementation and management of quality systems and procedures in compliance with applicable standards and regulations (FDA 21 CFR Part 820, ISO 13485, Medical Devices Directive, etc.) with the ultimate goal of supporting commercial readiness. The individual will also work with cross-functional teams to support the clinical development of Ichor’s proprietary medical devices and the preparation of regulatory filings for biologic and medical device product candidates, including NDAs, Master Files, and registration packages for various regulatory jurisdictions globally.
Develop and manage continuous quality improvement activities by applying principles of FDA 21 CFR Part 820 Quality System Regulations, ISO 13485:2016, IEC 62304 and other applicable regulations
With Ichor management develop and implement a stage-appropriate quality/regulatory strategy to move from development through commercial readiness
Maintain internal systems and coordinate quality oversight (CAPA, complaint handling, medical device reporting, change order processing, etc.) in compliance with approved procedures and regulatory requirements
Oversee daily activities of the quality staff in the development, implementation and maintenance of Ichor’s quality systems
Responsible for ensuring all stages of product design and manufacturing are performed in compliance with approved procedures and regulatory requirements
Coordinate, lead the preparation for and manage customer and regulatory inspections of Ichor and its contract manufacturing facilities/operations
Responsible for oversight of the supplier qualification program (including the creation and maintenance of quality agreements, ensuring site audits are performed when needed, reviewing audit reports/observations and assessing and addressing issues with suppliers)
Responsible for ensuring that contract design, testing and manufacturing documentation is reviewed in a timely manner and complies with approved procedures and regulatory requirements
Responsible for oversight of cGMP document control, including maintenance of design, manufacturing, quality and regulatory records and archives
Actively drive and participate in the risk management process with cross-functional teams and determine appropriate plans to address quality and compliance risks
Responsible for coordinating quality oversight of process validation and change control to ensure validation of and changes to cGMP processes, tests, equipment and facilities are performed, as required, and meet regulatory requirements
Responsible for coordinating quality oversight of investigation activities (related to nonconforming materials, complaints, CAPAs, etc.) to ensure they are adequate and that appropriate corrective action is implemented in compliance with approved procedures, regulatory requirements and customer agreements
Coordinate quality oversight of product inventories and inventory control, including receiving, quarantine, shipment, disposition, etc.
Participate in design reviews, including risk assessment, as required
With other management, coordinate and conduct regular management review to ensure management is informed of compliance/quality concerns, quality projects, quality metrics, nonconforming product, complaints, supplier performance, etc.
BS or BA in engineering or a life science
At least 10-15 years of experience in quality assurance for the development of medical devices
Minimum of 8-10 years of supervisory experience
Minimum of 8 years of experience and/or certification as an auditor in an FDA or ISO regulated industry
Experience with managing/leading quality system inspections by regulatory authorities, particularly FDA and Notified Bodies
Thorough knowledge of Quality System Regulations for medical devices (e.g., 21 CFR Part 820 and ISO 13485:2016) and demonstrated ability to apply comprehensive, in-depth understanding of such medical device standards and regulatory requirements to design controls and contract manufacturing
Experience with the application and implementation of risk management to medical devices (e.g., ISO 14971)
Expert knowledge of current industry practices in quality systems for the development of medical devices
Combination of US and EU regulatory compliance experience preferred
Coursework/certificates in quality and/or regulatory topics, or equivalent experience preferred
Experience with standards for medical device software development (e.g., IEC 62304) preferred
Highly effective verbal and written communication skills
Quick learner with the ability to keep up with and adapt the Quality System for changing processes and regulatory requirements
Team player with experience in a small company environment and the desire to take a hands-on role in the implementation, maintenance and management of the quality system
Proficient computer skills to operate Microsoft Word, Project, and Excel
Application Information & Contact (How to Apply)
Please e-mail Bianca Cardiel at firstname.lastname@example.org with your cover letter and resume please.
Learn more about Ichor Medical Systems here.