Sr Quality Operations Manager

MiniMed•Juncos, PR

6d•Onsite

About The Position

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.

Requirements

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 Haves

Bachelor's degree in Science (Engineering Degree preferred)
Previous experience leading Quality Operations, Compliance, QMS and Audit department.
Previous experience leading FDA & Regulatory Bodies inspections / Audits.
Regulatory experiences.

Responsibilities

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
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.
Partner 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.
Serve 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.
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.