Quality System Senior Specialist

יקנעם
משרה קבועה
משרה מלאה

לפני 3 שעות

We anticipate the application window for this opening will close on - 1 Nov 2025At 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 Life Medtronic seeks a Senior Quality Systems Specialist to develop and maintain quality programs for medical devices. The role ensures compliance with regulatory standards and supports quality improvement initiatives.This hybrid position is based in Yokneam, Israel/Santa Clara, California/ Lafayette, Colorado facilities. The role requires occasional travel and involves independent work to maintain quality standards across global operations.Responsibilities may include the following and other duties may be assigned:

Provide oversight for development and maintenance of quality management systems, ensuring full compliance with FDA, ISO 13485, and other regulatory requirements
Lead audit and inspection preparation activities, coordinate with regulatory bodies, and manage resolution of findings through comprehensive Corrective and Preventive Actions (CAPA)
Conduct process analysis and risk assessments to identify improvement opportunities and ensure adherence to quality standards across manufacturing and design operations
Collaborate with cross-functional teams to interpret regulatory requirements and implement quality policies that support our endoscopy and surgical device portfolios
Prepare detailed quality reports and documentation for internal stakeholders and external regulatory agencies
Facilitate global quality standards implementation and best practice sharing across international sites

Required Knowledge and Experience:

Bachelor's degree in Engineering, Life Sciences, or related field with minimum 4 years of quality systems experience in medical device industry
Strong knowledge of medical device regulations including FDA Quality System Regulation (QSR), ISO 13485, and Good Manufacturing Practices (GMP)
Proven experience with audit management, CAPA processes, and Management review preparation
Demonstrated ability to interpret complex regulatory requirements and translate them into actionable quality procedures
Excellent analytical and problem-solving skills with experience in process improvement methodologies
Strong communication abilities to interact effectively with senior management, regulatory agencies, and cross-functional teams

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.The physical demands described within the Responsibilities 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.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.
Salary ranges for U.S (excl. PR) locations (USD):$89,600.00-$134,400.00U.S. CandidatesThe following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.Further details are available at the link below: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
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

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