Sr Quality Systems Supv.

Medtronic; Puerto Rico; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medtronic Incentive Plan (MIP)

Competitive benefits package

Job summary

Medtronic in the United States seeks a Senior QA Supervisor to lead day-to-day quality assurance operations, guiding QA team members and ensuring adherence to quality processes across the business.

This role partners with internal stakeholders to manage quality risks, lead audit preparation, and drive corrective actions while maintaining compliance with policies and regulatory standards, contributing to Medtronic's mission to alleviate pain and extend life.

Qualifications

• Baccalaureate degree required; international equivalents must satisfy 8 C.F.R. § 214.2(h)(4)(iii)(A) and provide minimum 3 years relevant experience.
• Advanced degree with minimum 1 year relevant experience.
• Nice to have: Green belt certification and problem-solving techniques (Kepner-Tregoe, DMAIC).
• Knowledge in statistical techniques and risk management standards.

Responsibilities

• Oversee QA programs, systems, processes to ensure compliance with internal/external standards.
• Provide guidance interpreting policies and regulatory requirements.
• Collaborate with operating entities to enforce requirements and meet regulations.
• Lead audit/inspection preparation and resolution of findings with auditors.
• Prepare reports and corrective/preventive actions for stakeholders.
• Coordinate legal requests for investigations or litigations.
• Maintain and update QA programs and policies; promote a culture of quality.
• Foster uniform worldwide standards and share best practices.

Skills

Problem solving

Regulatory experience

Green belt

Kepner-Tregoe

DMAIC

Statistical techniques

Risk management standards

Education

Baccalaureate degree

Advanced degree

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.A Day in the LifeA career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.The Senior QA Supervisor oversees day-to-day quality assurance operations, provides leadership and coaching to QA team members, and ensures consistent application of quality processes. This role monitors quality performance, supports investigations and corrective actions, and collaborates with internal stakeholders to identify and manage quality risks. The Senior QA Supervisor also helps maintain compliance with company policies and regulatory standards while promoting a culture of quality, accountability, and continuous improvement.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.Works directly with operating entities to provide process analyses oversight on a continuing basis 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/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.Co-ordinates 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 achievement of company's mission globally.Required Knowledge and Experience: Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution.Requires advanced knowledge of job area obtained through advanced education combined with experience.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 3 years of relevant experience, or an advanced degree with a minimum of 1 year of relevant experience.Nice to have:Problem solvingExperience with regulatory agencyGreen belt certifiedKnowledge in problem solving techniques-Kepner tregoe, DMAIC.Knowledge in statistical techniques and Risk Management standardsFor Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.Physical Job RequirementsThe 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.U.S. Work Authorization & SponsorshipAt Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.Recruitment Fraud AlertWe are aware of phishing scams targeting job seekers. Please keep the following in mind:Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [e-mail] .Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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.This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).Medtronic benefits and compensation plansIt 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 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.