Senior Quality Applications Specialist

We anticipate the application window for this opening will close on - 24 Oct 2025

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

Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver resultsthe right way. Thats the Medtronic Mindset our cultural norms. Our brand is rooted in action not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better healthier lives.

At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Responsibilities may include the following and other duties may be assigned :

Partner with change management process development resources and draft new and revised documents necessary to support users in their effective efficient and compliant usage of Product Lifecycle Management (PLM) capabilities and compliance with business process requirements

Partner with document owners at all levels (Enterprise Shared Local etc.) to ensure alignment is maintained between documented processes

Be proficient in working within medical device Quality Management System change control requirements

Advise enterprise- and local-level stakeholders on potential impacts resulting from documents created and revised

Consult Product DNA experts on usage of the PLM system to create and manage change workflows parts documents contexts resources etc.

Host stakeholder reviews and disposition feedback

Route release and effect changes in PLM to support release go-lives

Work with translations teams to clarify content as needed

Advise training teams as needed to inform training content creation and revision

Use PLM systems proficiently to help verify system behavior (e.g. step sequence required fields system validations etc.)

Must Have : Minimum Requirements

To be considered for this role please ensure the minimum requirements are evident on your resume .

Bachelorsdegree with 4 years of work experience in Quality or regulated industry OR Advanced degree with 2years of work experience in Quality or regulated industry.

Nice to Have ( Preferred Qualifications )

Bachelors degree in relevant field required with a minimum of 7 years of Quality Management System Document Writing and / or Regulatory experience in medical device or regulated industryOR advance degree with a minimum of 5 years Quality Management System and / or Regulatory experience in medical device or regulated industry.

Ability to write clear concise and comprehensive instructions

Experience with Medtronics Enterprise Windchill configuration of PLM change workflows parts documents contexts resources etc.

Ability to expertly navigate software

Experience developing document content (e.g. work instructions job aids technical guides) that promotes efficient and effective business processes with emphasis on ease of use and understanding by a broad audience with varying expertise

Experience incorporating user feedback

Excellent organizational and time management skills

Effective verbal and written communication skills and the ability to tailor communication for different audiences

Good balance of high-level strategic and detailed tactical thought processes

Demonstrated track record of successfully driving deliverables to completion under tight time constraints

Ability to strongly advocate for and represent DNA Implementation to a cross-functional team related to project and business needs

Proficient at simplifying and communicating complex business challenges to stakeholders with varying backgrounds and levels of understanding

Results-oriented and able to drive accountability in others

Demonstrated capacity for strategic thinking

Excellent communication skills and interpersonal / team effectiveness

Business acumen ability to think from an overall best for the business perspective

Solid understanding of the CMII process including interchangeability rules and revision and effectivity of changeables

Previous implementation / configuration of a PLM change process for one or more customers

Previous participation in a PLM change process as one of the change administrators change task assignee or change task approver or equivalent role as active user performing change

Solid understanding of change notice templates product lifecycle maturity and interaction of changeables with a PLM business rules framework

Experience with the regulatory and UDI data objects

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.

Salary ranges for U.S (excl. PR) locations (USD) : $94400.00 - $141600.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience certification / education market conditions and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The 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 :

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 find here 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

Key Skills

Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 94400 - 141600