Senior Quality Systems Manager

תיאור התפקיד

Careers That Change Lives

In this exciting role as a Senior Design Quality and Compliance Manager, you will have responsibility for leading and managing quality assurance of medical device products and managing the quality management system in Medtronic’s Patient Monitoring business.

The Jerusalem based Design Quality team you will lead ensures that design control is properly maintained and executed, released products meet performance expectations, and changes to current product designs and service/repair of products in the field follow the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies. 

The Jerusalem based compliance team you will lead oversees the compliance and customer quality activities such as: preparing and hosting the site management review, running the Corrective Action Board, managing internal and external audits, reviewing and completing activities defined in customer quality agreements, and handling document control. In addition, you will provide leadership, oversight and training to Quality and Engineering on a broad range of topics including change control, risk management, trending & escalation, statistical methods, and CAPA. 

 

A Day in the Life

You will Oversee and manage Quality Engineers who provide quality support to new product development, design changes and sustaining engineering projects.

You will Provide strategy and structure for released product quality support including complaint trending, escalation, CAPA investigation and execution.

You will Establish complaint and reliability predictive metrics to drive improvement in the business.  Support Design for Reliability and Manufacturability initiatives.

You will Oversee and manage the Quality System specialists who maintain the quality management system including management review, CAB, internal audit scheduling, quality planning, customer quality, and document control.

You will Support activities such as Issue Impact Assessment, product holds, field corrective actions, and regulatory requests for additional information.

You will Interact with auditing body agencies during audits.

You will Manage department resource allocation across multiple functions.

You will Drive change, demonstrate effective decision making, and provide direction for quality operations.

You will Provide guidance and development opportunities for department employees.

דרישות התפקיד

Must Have: Minimum Requirements

BSc in Engineering with strong background in electronics and software.

Quality Auditor experience for ISO13485.

Previous supervisory responsibility

7-10 years in quality engineering with at least 5 years in the medical device industry, or equivalent work experience and/or professional qualifications. 

Nice to Have (Preferred Qualifications)

Six Sigma or Lean Certification(s) desired

Quality Certifications: e.g. Certified Quality Engineer/ Manager, Certified Reliability Engineer, Certified Quality Auditor

Excellent communication skills

Ability to work effectively within team and across functions

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

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