Sr. Quality Systems Specialist
Sr. Quality Systems Specialist
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Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.The Sr. Quality System Specialist position is one of development improvement and innovation through cross functional collaboration. If you pride yourself on your problem-solving skills meticulous attention to detail and passion for quality this may be the role for you. You will be tasked to provide quality systems support in development and maintenance of medical device products across the Acute Care and Monitoring ACM portfolio of products. Facilitate the application of our Quality Management System in developing and sustaining our product portfolio.
Responsibilities may include the following and other duties may be assigned.
- Provides oversight for the development and maintenance of 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/or governmental regulations and internal regulations to assure compliance (FDA & International Medical Device Directives / Regulations ISO requirements etc.).
- Partnering with and influencing internal and external stakeholders to drive needed change and the execution of compliance program.
- Maintains and develops the ACM OU training program (Cornerstone On Demand CSOD) and process.
- Supports audit and inspection preparation resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Owns and drives investigations Root Cause Analysis and resulting Corrective and Preventive Actions and creates reports and/or necessary documentation and provides to applicable stakeholders both internal and external.
- Investigates and resolves compliance problems questions or complaints received from other units of the company customers government regulatory agencies etc.
- Maintains Key Performance metrics and performs trend analyses and reports compliance observations to identify areas in need of improvement.
- Applying statical methodology in tracking and trending Quality metrics and developing models/visual representation of the data.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Facilitates uniform standards worldwide and enables best practice sharing thereby fostering the achievement of companys mission globally.
- Excellent writing and editing skills and computer skills in the English language.
- Ability to travel within the US and Internationally on occasion.
Must Have: Minimum Requirements
- Bachelors degree required
- Minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years of relevant experience
Nice to Have
- Auditing Experience
- Learning Management System experience (Cornerstone on Demand) and training program management
- Statistical Analysis and Visualization tools (Power BI etc.)
Physical Job Requirements
The 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 & Compensation
Medtronic 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.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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:
Medtronic benefits and compensation plans
About Medtronic
We 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 95000 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 here.
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 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 findhere 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.
Required Experience:
Senior IC
Employment Type
Full-Time
