Quality Systems Specialist

MPI Medtronic Philippines, Inc; Taguig; On-site; PHP 900,000 - 1,500,000; Full time

Benefits offered by this job

Medtronic Incentive Plan (MIP)

Competitive compensation

Job summary

Medtronic Philippines, Inc. in Taguig is seeking a Quality Systems Specialist to support regional audit programs and the QMS across operations.

You will drive supplier audits, track corrective actions, and ensure compliance with ISO 13485 and GMP/GDP, partnering with cross-functional teams to improve quality performance. The role requires a 3+ year quality background in healthcare, Lead Auditor credentials, and strong English communication, with opportunities for professional growth in a global

Qualifications

• 3+ years in a quality role within healthcare.
• Experience with ISO 13485 and GMP/GDP.
• Lead Auditor or Internal Auditor certification.

Responsibilities

• Manage internal, external, and supplier audit activities and track corrective actions.
• Provide training on audit processes and QMS requirements.
• Monitor KPI metrics and develop corrective plans when targets are not met.
• Collaborate with cross-functional teams to strengthen QMS compliance.
• Interpret quality policies and regulatory requirements for the organization.
• Support QMS-related projects and process enhancements.
• Maintain quality documents in line with QMS requirements.
• Contribute to regional service agreements and quality initiatives.

Skills

Quality auditing

ISO 13485

Lead Auditor

English proficiency

Project management

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences/Engineering/Biomedical Engineering or related discipline

Tools

TrackWise

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 Life

The Regional Compliance and Quality Systems (CQS) function supports quality management system (QMS) compliance, audit readiness, supplier quality oversight, and continuous improvement initiatives across the region. This team partners with operating units and quality stakeholders to ensure alignment with internal quality requirements, regulatory expectations, and industry standards, while driving consistency and effectiveness across audit and QMS processes. The Quality Systems Specialist serves as a subject matter resource for internal and external audits, supplier audit activities, QMS projects, and compliance programs. The role works closely with cross-functional teams to monitor performance, support quality objectives, drive corrective actions, and strengthen compliance across regional operations.

The Quality Systems Specialist is responsible for supporting regional audit and quality management system activities, ensuring compliance with applicable quality requirements and industry regulations. This role provides guidance on audit programs, quality processes, performance metrics, and continuous improvement initiatives while partnering with stakeholders across the organization to strengthen quality system effectiveness.

Primary Responsibilities

• Manage and support internal, external, and supplier audit activities, including audit observations and corrective action tracking.
• Provide training and guidance on audit processes, quality management system requirements, and TrackWise utilization.
• Monitor audit, change control, and QMS key performance indicators and develop corrective or mitigation plans when targets are not achieved.
• Partner with operating groups and quality stakeholders to monitor compliance activities and drive process improvements.
• Interpret quality policies, procedures, and regulatory requirements to ensure organizational compliance.
• Participate in audit and QMS-related projects and support implementation of process enhancements.
• Maintain assigned quality documents and processes in alignment with applicable QMS requirements.
• Support additional responsibilities and quality initiatives defined within regional service agreements.

Required Qualifications

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Biomedical Engineering, or related scientific discipline with 3+ years of experience in a quality role within the healthcare industry.
• Experience with ISO 13485 and/or GxP requirements, including Good Distribution Practice (GDP) or Good Manufacturing Practice (GMP).
• Lead Auditor or Internal Auditor certification in a Quality Management System standard such as ISO 13485 or GMP.
• Fluent English communication skills.
• Experience managing projects and working across geographically dispersed teams.

Preferred Qualifications

• Experience writing, reviewing, and maintaining technical documentation.
• Knowledge of medical device regulations and applicable Food and Drug requirements.
• Strong understanding of ISO 13485 and quality management system processes.
• Experience evaluating compliance risks and making compliance-based decisions.
• Ability to build cross-functional relationships and influence stakeholders across multiple functions.

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.

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). 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 95,000+ 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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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. For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email [e-mail] To request removal of your personal information from our systems please email [e-mail]