Sr Quality Systems Program Dir

at  Medtronic

At 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
Careers that Change Lives
The Sr Program Director, Complaint Handling Next-Gen will lead and own a large cross-functional program to develop and replace complaint handling processes and quality information technology systems (eQMS) to state of the art (SOTA) solutions that align with Core Quality Services goals and objectives. They will partner closely with functional teams across Medtronic that interact with the life cycle of our complaints including Operating Units, Manufacturing, Field, etc. The person in this role is accountable for the overall success of the programs they manage, including program objectives, timelines, milestones, and budgets.
This role reports directly to the VP of Customer Quality. The person in this role will assist the Customer Quality Organization in setting direction and strategy for long term success of our entire eQMS vision.
A Day in the Life

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

• Lead a cross-functional team of Project Mgmt, Technology SMEs, Process SME’s, and IT professionals to define and implement a large scale Enterprise Complaint Handling system with SOTA automation and AI/ML technologies. Ultimately accountable for program timing and outcomes.
• Provides oversight for development and maintenance of eQMS Quality programs, systems, processes, and procedures to ensure compliance with policies per defined schedules.
• Leads harmonization of complaint handling coding for efficiency and consistency across businesses.
• Assesses operating unit / business readiness for new configurations and data requirements.
• Programs impact large segments of the Enterprise requiring the ability to manage a portfolio of separate upgrades / projects in parallel.
• Oversees and manages operational aspects of projects and serves as liaison with effective executive communication skills for project teams and operating unit / business unit management.
• Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.
• Develops mechanisms for monitoring project progress. Reviews status of programs through reports, manages budgets, and schedules.
• Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives. Intervenes for problem solving with project / business managers and clients.
• Responsibilities include, but are not limited to, analysis, selection and modification of enterprise systems and application software in compliance with validation process for quality information technology systems.
• Ensures the performance of vendor services conform to established internal and external standards and guidelines.
• Coordinates activities with clients, programmers/developers, and operating personnel globally.
• Identifies current and anticipated requirements for implementation and maintenance of procedures, actions and documentation necessary to assure compliance to regulations.
• Provides guidance in interpreting policies, governmental regulations, and internal regulations.
• May lead audit and inspection preparation, including resolution of audit and inspection findings.
• Prepares necessary documentation (ex Corrective and Preventative Actions) for applicable stakeholders, both internal and external.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company’s mission globally.
• Selects, develops, and evaluates personnel within Programs to ensure outcomes are achieved.

Must Have: Minimum Requirements

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

• Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 15 years of quality experience with 10+ years of managerial experience, or advanced degree with a minimum 13 years of qualityt experience and 10+ years of managerial experience.
• Previous experience leading and implementing large scale IT Quality Management Systems (QMS) system that included data migration and/or replacement..
• Experience in Quality Management Systems (QMS)

Nice to Have: Preferred Requirements

• Experience with Information technology Capital Investments and Implementations across Large Organizations (500+ Users)
• Demonstrated ability to lead people and achieve results through others.
• Strong cross-organizational collaboration skills; ability to operate effectively in a matrixed environment.
• Strong communication and presentation skills

About Medtronic
Together, 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 Requirements
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. (ADA-United States of America)
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. Learn more about our benefits
here
.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP)
here
.
This position is eligible for an annual long-term incentive plan. Learn more about Medtronic Long-Term Incentive Plan (LTIP)
here
.
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).
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):$211,200.00 - $316,800.00
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).This position is eligible for an annual long-term incentive plan.
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).
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 90,000+ 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
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.
At Medtronic, most positions are posted on our career site for 3-7 days

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

• Lead a cross-functional team of Project Mgmt, Technology SMEs, Process SME’s, and IT professionals to define and implement a large scale Enterprise Complaint Handling system with SOTA automation and AI/ML technologies. Ultimately accountable for program timing and outcomes.
• Provides oversight for development and maintenance of eQMS Quality programs, systems, processes, and procedures to ensure compliance with policies per defined schedules.
• Leads harmonization of complaint handling coding for efficiency and consistency across businesses.
• Assesses operating unit / business readiness for new configurations and data requirements.
• Programs impact large segments of the Enterprise requiring the ability to manage a portfolio of separate upgrades / projects in parallel.
• Oversees and manages operational aspects of projects and serves as liaison with effective executive communication skills for project teams and operating unit / business unit management.
• Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.
• Develops mechanisms for monitoring project progress. Reviews status of programs through reports, manages budgets, and schedules.
• Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives. Intervenes for problem solving with project / business managers and clients.
• Responsibilities include, but are not limited to, analysis, selection and modification of enterprise systems and application software in compliance with validation process for quality information technology systems.
• Ensures the performance of vendor services conform to established internal and external standards and guidelines.
• Coordinates activities with clients, programmers/developers, and operating personnel globally.
• Identifies current and anticipated requirements for implementation and maintenance of procedures, actions and documentation necessary to assure compliance to regulations.
• Provides guidance in interpreting policies, governmental regulations, and internal regulations.
• May lead audit and inspection preparation, including resolution of audit and inspection findings.
• Prepares necessary documentation (ex Corrective and Preventative Actions) for applicable stakeholders, both internal and external.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company’s mission globally.
• Selects, develops, and evaluates personnel within Programs to ensure outcomes are achieved

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

• Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 15 years of quality experience with 10+ years of managerial experience, or advanced degree with a minimum 13 years of qualityt experience and 10+ years of managerial experience.
• Previous experience leading and implementing large scale IT Quality Management Systems (QMS) system that included data migration and/or replacement..
• Experience in Quality Management Systems (QMS