At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.
About the Role
Lead the systems that protect patients and drive regulatory excellence. As a key leader within our Quality Management System (QMS) organization, you will provide strategic oversight and hands-on direction across our compliance, internal audit, and CAPA programs at our Juncos manufacturing facility.
What You'll Own:
Maintain continuous audit-readiness and regulatory compliance (21 CFR Part 820, ISO 13485, MDSAP, GMED, and more)
Lead and develop a multifunctional quality team
Drive accountability across quality subsystems
Serve as the primary interface with notified bodies, regulatory authorities, and the FDA
If you are passionate about quality leadership and making a meaningful impact in the medical device industry - this role is for you!
Responsibilities may include the following and other duties may be assigned.
The Senior Quality Operations Manager, Compliance & Audit engage in daily tier meetings and cross-functional forums - including CAPA Review Boards and Compliance Risk Burn Down sessions - where they actively drive action plan accountability, prioritize key quality system activities, and ensure timely closure of open compliance items across the site. Throughout the day, this leader partners closely with site leadership and operations teams to align on manufacturing quality performance, escalate emerging risks, and maintain the site's audit-ready posture across CAPA, DHR, NCMR, and regulatory inspection readiness workstreams. From morning stand-ups to end-of-day leadership touchpoints, serves as the connective thread between quality systems, operational execution, and regulatory accountability - ensuring that every team, process, and metric is moving in the right direction to sustain a culture of continuous compliance in a fast-paced medical device manufacturing environment .
Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.
Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.
Interprets and implements applicable regulations as they apply to products, processes, practices and procedures.
May counsel stakeholders about these requirements as necessary.
Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.
Develops and implements programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Requires Bachelor's degree
Requires minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience.
Nice To Have:
Bachelor's degree in Science (Engineering Degree preferred)
Previous experience leading Quality Operations, Compliance
Previous experience leading FDA & Regulatory Bodies inspections / Audits.
Regulatory experiences.
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
MiniMed offers a competitive salary and flexible benefits package
At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.
This position is eligible for a short-term incentive called the Short Term Incentive (STI).
MiniMed Benefits (http://myminimedbenefits.com) Overview
About MiniMed
MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey - when and how they need it. For more than 40 years, we've been committed to redefining what's possible: intelligent dosing systems designed for real life, predictive insights that stay a step ahead, and always on support when it's needed most. At the heart of everything we do is a simple Mission: to make every day a better day for people with diabetes.
Learn more about our business, and our mission here (https://www.minimed.com/en-us/about-us/) .
It is the policy of MiniMed 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, familial status, membership or activity in a local human rights commission, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for MiniMed 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 (http://www.minimed.com/en-us/la-county-legal-notice) a list of all material job duties of the specific job position which MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. MiniMed 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.
