Director Quality Assurance
Company: Affinity Executive Search
Location: San Francisco
Posted on: May 15, 2022
Director, Quality Assurance Director (Dir QA) will work with the
team to lead the evolution of the Quality Management System (QMS)
and Design Assurance. responsible for leading Quality Operations
and R&D Quality in addition to establishing and maintaining a
Quality management system in accordance with relevant regulatory
requirements for medical devices. Dir QA will lead the QA
department, which includes QA Inspection, Document Control,
Complaint Handling, Corrective and Preventive Action, Equipment
Calibration, Supplier Management, Training, process validation, and
maintenance of the Device History Records. supports
cross-functional teams e.g. R&D and Manufacturing with design
changes, tech transfer, and complaint investigation effort.
Responsible for planning of quality related projects in alignment
with company goals.
--- Works with R&D and Operations to establish quality
requirements at all phases of product/process development and
--- Ensures R&D teams are compliant with design control
requirements and procedures.
--- Manages and supervises all activities of the QA, QC and QE
--- Assists in the creation, development, submission, and pursuit
of regulatory clearances both in the US and OUS.
--- Responsible for submission of all adverse event information as
required by the Medical Device Reporting regulation and the
vigilance system or any other applicable regulatory
--- Serves as the Quality reviewer/approver for document control
and other QMS processes.
--- Researches and provides guidance to the design team regarding
standards and regulations applicable to the development
--- Develops and implements specific testing for existing and new
products including supporting design and process validations,
qualifications and first article inspections.
--- Provides input to Risk Management efforts for products and
--- Provides support to manufacturing process development,
validation, and inspection.
--- Develops test and inspection procedures.
--- Manages activities for incoming, in-process, and final
inspection and test related tasks.
--- Ensures that appropriate level of quality and reliability of
purchased components is specified.
--- Manages the Supplier Controls system to ensure that suppliers
are approved in accordance with company procedures and regulatory
--- Conducts supplier evaluations including supplier audits.
--- Ensure personnel are trained per internal and external
--- Ensures CAPA, internal audits, calibration, and preventive
maintenance works effectively.
--- Serves as the Management Representative for the Quality
--- Comply with company quality system requirements as well as any
applicable regulatory requirements.
--- Comply with all health and safety regulations, policies, and
--- A minimum of 8 years of experience in Quality Assurance in the
Medical Device industry; including 3+ years' experience managing
--- Experience with Class III active implantable devices is
--- Experience with software and firmware V&V is preferred.
--- Experience with FDA (21CFR 820), ISO 13485, and ISO14971
--- Experience in Quality systems implementation and
--- Experience in approval and audits of Class II and III medical
--- Experience in complaint handling process.
--- Experience in training, calibration, and preventive maintenance
--- Experience in design verification and validation methods.
--- Experience in implementing and managing document control
--- The ability to work independently.
--- Excellent verbal and written communication skills.
--- Excellent interpersonal skills and a spirit of teamwork.
--- Bachelor's degree (B.S.) in Engineering or Science or related
--- Master's degree (M.S.) preferred.
Keywords: Affinity Executive Search, San Francisco , Director Quality Assurance, Executive , San Francisco, California
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