Job Title

Head of Quality, Korea

Job Description

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better

You will contribute with your expertise in Operational Quality towards ensuring compliance of Philips commercial organization in Korea. You will work extensively with the district leadership team to deploy Quality Management System, oversee local Post Market Surveillance and maintain compliance to Philips Policies and applicable local regulations. You will also have the opportunity to work in a highly matrix organization across functions.

You are responsible for

  • Philips Korea’s QMS Management compliance and tracking of Quality related KPIs in accordance with ISO 13485, Korea Medical Device Regulations and Philips policies.
  • Deploying global quality objectives with necessary local additions (or adjustments) to drive sustained improvements to QMS.
  • Be part of district Leadership Team, manage team budget, and set-up strategic plans in alignment with function & business goals.
  • Drive adherence to compliance and process improvement, through effective use of CAPA process.
  • Supporting Quality & as well Regulatory Capabilities including Supplier Quality/ PQMS.
  • Represent Philips at local authorities e.g. MFDS
  • Ensuring timely submission of Medical Device and Safety Vigilance Reports within the defined time to Regulatory Agencies/ Competent Authority (CA). 
  • Tracks status of reported incidents with Competent Authority ensuring all cases are closed by CA following adequate submission of objective evidence.
  • Coordinates extensively with various manufacturing sites on product quality/ customer complaints or recall actions.
  • Oversees recall & correction management through effective Customer & CA Communication, tracking of Field Actions, good record tracing and closure of actions with local authority.
  • Manages customer feedback by ensuring right owners respond/ resolve in timely manner.
  • Works collaboratively with Customer Service and SCM organizations.
  • Oversees personnel training for QMS processes.
  • Lead the internal & External audit program for the district.
  • Lead the management review for the district.
  • Lead country quality team through coaching, developing and supervising for success.

We are looking for someone with the following skills, knowledge and experience

  • Bachelor’s/ Master’s Degree in Quality Management/Engineering/Science/Technical discipline.
  • More than 10 years of Quality Management and/or Regulatory Affairs experience in the medical devices industry.
  • Expertise in driving operational quality related improvement strategies to address compliance, product quality issues – both from oversight, leading and facilitating others.
  • Competent in delivering trainings in the various Operational Quality & lean tools to drive improvements in a quality arena.
  • Experienced in working in an Operational Quality environment, including in quality management systems is required. Knowledge of ISO 13485 is required.
  • Demonstrated ability to work with senior/executive leaders and be able to engage/influence cross functional leadership teams.
  • Good experience working with MFDS, local authorities, and Notified Body audits and inspections with favorable outcomes.
  • Proven leadership ability to carry out difficult decisions in a logical, rational manner and work with senior leadership management team member and to engage and influence team members in a matrixed environment.

How we work at Philips

There are three core ways that define our ways of working - embracing flexibility, being at our best, and impactful collaboration. We believe this enables us to deliver an outstanding experience to our customers and create the best place to work for people who share our passion.

We know just how important direct interactions are and work is more engaging when we are more frequently face-to-face, and that we experience better collaboration which drives innovation. While we have many different types of roles across Philips most require a combination of in-person collaboration with colleagues and partners, usually at a Philips location, and individual focus time, which can be done remotely.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Visit our careers website to explore what it’s like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some frequently asked questions.