Reporting to the Head of QA/RA, the QA operations manager manages quality engineers' team, develops quality skills, and pilots the activity.
Manage the QA Operations group to ensure manufacture, testing and release of products is carried in a compliant manner and in adherence to the required manufacturing, testing, and release schedules. This role will work closely with the production, operation, engineering, QC and QA teams.
Provide QA oversight and input to all site activities including review and approval of nonconformities, deviations, batch records, environmental monitoring reports, maintenance and calibration reports, specifications, Standard Operating Procedures, Manufacturing Procedures.
Pilot quality operation's team, manage capacity and priorities. Provide visibility of future resource needs. Oversees the team members' recruitment.
QA Manager will assist QA/RA Director in managing the QA team activities and in identifying and implementing quality system improvements, specifically for elements related to product quality.
Performs internal audits of the Quality System and participates in external quality audits.
- Supervise QA team activities.
- Support the QA/RA Director in quality activities.
- Promote Good Manufacturing Practices.
- Overseas that quality assurance objective maintained.
- Assures compliance to in-house and external specifications and standards.
- Participate in second- and first-party audits.
- Writes, review and approval of company document's, specifications, drawing and procedures.
- Perform supplier and internal audits.
- Supervise the document control, corrective and preventive actions, deviations and change orders.
Support QA/RA Directive in ensuring Company's compliance with Quality System procedures and company policies.
Good working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD/MDR requirements.
Excellent writing skills with ability to write quality assurance reports and detailed procedures. Good presentation skills. Good interpersonal skills to interact with all levels of the company.
Knowledge in audit principles, procedures, and methods.
Experience in managing the audit process to achieve the defined audit objectives.
Ethical, truthful, sincere, honest, and discreet personality.
Attention to Quality & Detail, Decision Making & Problem Solving
Leadership, teamwork, and flexibility.
Education / Experience / Skills:
A diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, life-science, medicine, pharmacy, engineering, or another relevant discipline.
Knowledge in the field of medical devices and at least 5 years of professional experience in QMS and regulatory affairs of medical devices.
At least-5 years of management experience.
Able to communicate at all organizational levels.
Must have excellent reading, writing and communication skills in English and Hebrew.
Excellent reporting, teamwork, and time management skills
Ability to learn quickly, analyze problems, work independently, and organize and execute multiple work tasks.