Director Quality Assurance

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 manufacturing.
Ensures R&D teams are compliant with design control requirements and procedures.
Manages and supervises all activities of the QA, QC and QE Departments.
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 requirements.
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 project.
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 processes.
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 requirements.
Conducts supplier evaluations including supplier audits.
Ensure personnel are trained per internal and external requirements.
Job Description

Ensures CAPA, internal audits, calibration, and preventive maintenance works effectively.
Serves as the Management Representative for the Quality Management System
Comply with company quality system requirements as well as any applicable regulatory requirements.
Comply with all health and safety regulations, policies, and work practices.
Experience:
A minimum of 8 years of experience in Quality Assurance in the Medical Device industry; including 3+ years experience managing team members.
Experience with Class III active implantable devices is preferred.
Experience with software and firmware V&V is preferred.
Knowledge/skills/Abilities:
Experience with FDA (21CFR 820), ISO 13485, and ISO14971
Experience in Quality systems implementation and maintenance.
Experience in approval and audits of Class II and III medical devices.
Experience in complaint handling process.
Experience in training, calibration, and preventive maintenance systems.
Experience in design verification and validation methods.
Experience in implementing and managing document control systems.
The ability to work independently.
Excellent verbal and written communication skills.
Excellent interpersonal skills and a spirit of teamwork.
Education:
Bachelors degree (B.S.) in Engineering or Science or related field.
Masters degree (M.S.) preferred.