Operations Quality Systems Manager

you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life
you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
leading Medical Device company and searching for an Operations Quality Assurance Manager to lead quality operations team in Yokneam site. In this role, reporting directly to the EMEA Sr. Operations QA Director, you will manage team of Quality engineers conducting professional quality assurance procedures, in the field of endoscopy products and lead a site QMS strategy. The position is on-site, travel may be required up to 10% of the time.

Responsibilities may include the following and other duties may be assigned:
Act as Quality Management Representative.
Responsible for the Yokneam site quality management system.
Develop and implement a comprehensive QA strategy aligned with the company's overall goals and vision.
Ensures the quality assurance programs and policies are maintained and modified regularly.
Build and develop the capabilities of the quality team, fostering a culture of continuous improvement, innovation, and collaboration.
Implement Lean, Six Sigma, or other quality improvement methodologies.
Update company management on quality performance and policy implementation.
Responsible on MRB activities, periodic quality reviews, and provide actionable insights.
Responsible for CAPA management and risk assessment.
Co-ordinates legal requests in support of government investigations or litigations
Lead and ensure company compliance with quality standards and certifications as required.
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Collaborates with cross-functional resources to achieve desired results.
Understand and operate according to medical device regulatory guidelines (GMP, FDA, ISO13485, AIMD R-PAL) and company Quality System procedures.