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A Day in the Life

The Quality function is responsible for establishing, maintaining, and continuously improving quality systems that support regulatory compliance, development for New Product Introduction(NPI) and Manufacturing Transfer, product quality, and operational excellence across manufacturing operations. This role partners closely with site leadership, operations, and functional teams to ensure quality management systems remain effective, compliant, and aligned with internal standards and external regulatory requirements.
This position is based onsite at the Villalba, Puerto Rico manufacturing facility. The role requires regular presence at the site to support quality system oversight, audit readiness activities, regulatory inspections, and cross-functional collaboration.

         

         

Job Description field

The Senior Quality Systems Manager provides strategic and operational leadership for quality systems, compliance programs, and regulatory readiness activities. This role oversees quality processes that support regulatory compliance, audit preparedness, inspection management, and continuous improvement initiatives while driving quality system effectiveness across manufacturing operations.

Primary Responsibilities

• Lead the development, implementation, and continuous improvement of quality systems, programs, procedures, and compliance processes.
• Provide quality and regulatory expertise to ensure compliance with internal policies and applicable governmental and regulatory requirements.
• Partner with manufacturing and functional teams to assess processes, identify compliance risks, and implement sustainable quality improvements.
• Direct audit and inspection readiness activities, including preparation, execution, response coordination, and closure of findings.
• Oversee Corrective and Preventive Action (CAPA) activities and related quality documentation to support compliance objectives.
• Serve as the primary liaison with auditors, inspectors, and regulatory agencies during audits and inspections.
• Coordinate quality-related documentation and support activities associated with legal requests, investigations, and litigation matters.
• Drive standardization and best practice sharing to strengthen quality system performance across the organization.
• Provide Quality Systems leadership for New Product Introduction (NPI) programs, partnering with Operations, Engineering, Regulatory Affairs, and Quality teams to ensure compliant product launches, robust quality processes, inspection readiness, and sustainable quality system integration throughout the product lifecycle

Required Qualifications

• Bachelor's degree with a minimum of 7 years of relevant experience and 5+ years of managerial experience OR advanced degree with a minimum of 5 years of relevant experience and 5+ years of managerial experience.
• Experience leading Quality Management Systems in a regulated manufacturing environment.
• Experience managing regulatory audits, inspections, and remediation activities.
• Experience with Corrective and Preventive Action (CAPA) processes and quality compliance programs.
• Experience interpreting and applying regulatory requirements, quality standards, and company policies.

Preferred Qualifications

• Degree in Engineering, Life Sciences, Quality, or a technical discipline.
• Experience within medical device, pharmaceutical, biotechnology, or other highly regulated industries.
• Experience leading cross-functional quality improvement initiatives.
• Knowledge of global quality system regulations and industry standards.
• Experience supporting government investigations, legal requests, or litigation-related quality activities.

For 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 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.

U.S. Work Authorization & Sponsorship

At 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.

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Recruitment Fraud Alert

We 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 [email protected]. 

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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.
 

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

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 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.