Senior Quality Engineer Post Market Surveillance and Trending ;
Senior Quality Engineer Post Market Surveillance and Trending ;
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$ 96800 - 145200
1 Vacancy
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
Careers That Change Lives
A career at Medtronic is like no other. Were purposeful. Were committed. And were driven by our Mission to
alleviate pain restore health and extend life for millions of people worldwide.
In this exciting role as a Senior Quality Engineer in Medtronics Surveillance process within the quality organizations the incumbent will contribute to the Post Market Surveillance document writing process to ensure compliance to regulations and expectations of Regulatory Bodies. This is a scientific (engineering technical medical) writing position. This individual will partner with other teams such as Quality/Reliability Clinical Regulatory Affairs Product Development Medical Safety and Statisticians to collaborate and execute tasks in a timely manner.
Responsibilities may include the following and other duties may be assigned.
Contributes and authors Post Market Surveillance plans and report documents.
Develop therapy and product knowledge and apply this knowledge to surveillance of products.
Lead or participate in project teams to meet objectives related to process improvement hyperautomation (AI and machine learning) and overall strategy and timing of day to day work.
Provide input and feedback to ensure clear concise complete reports.
Collaborate with cross-functional team to assure high quality and successful completion of deliverables
Report on schedule timelines and deliverables
Author and lead cross functional team to review collected safety communications and compiled reports
Review inputs to annual reports summarizing CAPA FCA and IIA information
Review of key data elements to ensure no changes and consistency across various reports.
Contribute or participate in drafting responses to deficiencies from regulatory agencies.
Participate in review activities and approval of other documents authored by another function
Escalate and evaluation of signals during annual reporting
Qualifications
Must Have: Minimum Requirements
To be considered for this role please ensure the minimum requirements are evident on your resume.
Bachelors Degree in Engineering Science medical or technical field with 4 years of work experience in Medical Writing Engineering and/or Quality and/or Quality OR Advanced degree in Engineering Science or technical field with 2 years of work experience in Engineering and/or Quality
Nice to Have:
Detail oriented
Knowledge and apply this knowledge to post market surveillance of products.
Medical device experience; or experience in a regulated environment
Experience in deficiency writing and communication with regulatory authorities or notified bodies.
Ability to identify customer/stakeholder requirements and constructively respond to feedback/comments/inquiries
Analyzes complex issues and significantly improves changes or adapts existing methods.
Ability to work with very little direction towards predetermined long-range goals and objectives.
Proficient knowledge and understanding of medical terminology clinical practices physiology and/or applicable disease states Neuromodulation therapies and technologies
Ability to achieve objectives and milestones through identification and implementation of work plans and measurements.
Ability to identify and adapt to shifting priorities and competing demands
Knowledge and understanding of Good Clinical Practices Post Market Surveillance EU MDR Regulation Quality Management Systems Risk Management and other regulatory standards
Ability to work cross functionally with global partners in different time zones.
Experience and/or participation in projects that utilized hyperautomation (AI and machine learning)
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 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 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
