Operations Quality Systems Manager

ישראל
משרה קבועה
משרה מלאה

לפני חודש

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.Medtronic is 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 Medtronic 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.

Required Knowledge and Experience:

Bachelor’s degree in Engineering, Science, or Quality Assurance.
Experience of at least 5 years in a similar role in the Medical Device industry.
Regulatory experience with CE and FDA standards.
Proven ability to lead, influence, and motivate a high-performing team.
A proactive, resourceful mindset with the ability to lead in a fast-moving, lean environment.
Demonstrated skills in decision making.
Strong problem-solving, leadership, influence, and communication skills.
Outstanding written and verbal communication skills in English.
Ability to work across different cultures and time zones.
Proficiency in quality tools (FMEA, SPC, 8D, PPAP, GR&R).
Certifications such as Six Sigma or Lead Auditor (ISO 13485) are a plus.

Physical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).About MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.Learn more about our business, mission, and our commitment to diversity

Medtronic

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