Senior Quality Systems Specialist

Senior Quality Systems Specialist

31 Jan 2024
California, Menlopark, 94025 Menlopark USA

Senior Quality Systems Specialist

Vacancy expired!

Careers that Change LivesMedtronic pioneered the field of neuromodulation with the first commercially available spinal cord stimulator to treat chronic pain and engineered the first deep brain stimulation (DBS) system to treat movement disorders and the first implantable drug pump to deliver medication directly to the intrathecal space of the spine. More than 40 years later, we continue to innovate, constantly challenging ourselves to disrupt the markets we created. We advance science by thinking and acting boldly, bringing together the right people with the right breadth of expertise to engineer groundbreaking therapies and technologies.The Ear, Nose, and Throat Operating Unit is a global leader and trusted partner for innovative ENT solutions that improve patient access, outcomes, and customer satisfaction. We partner with the ENT community to understand the needs of customers and patients, delivering solutions that improve lives as we embody a culture of accountability and trust.Over the past 20 years, we have become the global market leader in three key segments – image-guided surgery, intraoperative nerve monitoring, and powered surgical instruments. We continue to launch valuable ENT solutions in tissue health and balloon sinus dilation.A Day in the LifeResponsibilities may include the following and other duties may be assigned.

Provides oversight for developing and maintaining quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.

Provides expertise and guidance in interpreting policies, regulatory and governmental regulations, and internal regulations to assure compliance.

Works directly with operating entities to provide process analysis oversight, continuing to enforce requirements and meet regulations.

Leads audit and inspection preparation, resolution of audit and inspection findings, and liaises with auditing groups and inspectors through all stages of the audits.

Prepares reports and necessary documentation (ex, Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.

Coordinates legal requests in support of government investigations or litigations.

Ensures the quality assurance programs and policies are maintained and modified regularly.

Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the global achievement of the company's mission.

Coordinates with Change Originators and Process Owners to facilitate changes within the various systems.

Review, Create, and Process Enterprise Change Orders for the site.

Must Have: Minimum Requirements

Bachelors degree required

Minimum of 4 years of quality systems experience or advanced degree with a minimum of 2 years experience

Nice to Have

Keen ability to give Attention to detail when reviewing quality documentation.

Ability to review and analyze changes from the change control system.

Ability to perform thorough and concise Gap Assessments on various quality processes.

Ability to fully implement new processes/systems that align with the architecture of QMS. Including writing new procedures and updating existing procedures as applicable.

About MedtronicTogether, 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 RequirementsThe 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.Committing to our employees' lives is at our values' core. We recognize their contributions. They share in the success they help to create.  We offer many benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here (https://www3.benefitsolver.com/benefits/BenefitSolverView?pagename=signon&conum=30601&coaffid=medtronic) .This position is eligible for a short-term incentive plan.  Learn more about Medtronic Incentive Plan (MIP) on page 6 here .The provided base salary range is used nationally (except in certain CA locations). The rate offered complies with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.Min Salary96800Max Salary145200It 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.

Job Details

Jocancy Online Job Portal by jobSearchi.