Quality Supervisor

hace 2 semanas

Buenos Aires, Buenos Aires C.F., Argentina Philips A tiempo completo

Job Title:
Quality supervisor


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
Ensure Quality and regulatory requirements are effective in all processes in scope.

Support the areas to comply with Competent Authorities Quality requirements.

Support for Quality Key Performance Indicators related to post-market surveillance.

Support PMS process across LATAM

You are a part of

  • A challenging, innovative environment with great opportunities for you to explore.
  • Building your career in an international company that brings innovations that matter to you
  • Fastpaced oriented work in a truly global environment

To succeed in this role, you should have the following skills and experience.
- knowledge of the quality control field.

  • Developing professional expertise, and applies company policies and procedures to resolve a variety of issues.
  • Has working knowledge of Philips products and services.
  • Support LATAM Region
  • English (written, spoken, attendance to meetings with people from different parts of the world)
  • Knowledge about Quality and regulatory requirements for Postmarket surveillance for LATAM countries.
  • Post Market surveillance experience
  • Working knowledge of appropriate global medical device regulations, requirements and standards such as ISO 13485, ISO 9001, FDA QSR, 21 CFR 806 and Global Regulatory Reporting requirements.
  • Works autonomously within established procedures and practices.
  • Typically acts as a lead, coordinating the work of others, but has no direct reports.
  • Needs adequate freedom to act, to determine HOW to solve occurring issues.

Key areas of responsibilities - Post Market Surveillance**- Submits C&R (FSN) Communication to the Competent Authorities and or other regulatory agency as required by Country/Market.

  • Submits and follow up C&R (FSN) Communication to customers and distributors along LATAM as required by Country/Market based on regulation and Philips procedures.
  • Archive evidence of communication of C&R (FSN) to Competent Authorities and or other regulatory agency and customers using the tools and procedures defined by the company.
  • Close Q&R work orders in ServiceMax including the proper evidence for due diligence process.
  • Monitor and report on metrics on the C&R (FSN) KPI's and generation of periodic reports.
  • Escalate KPI ́s when needed to ensure timely closure.
  • Interface with Service teams regarding FCO implementations.
  • Coordinate and or create C&R (FSN) file documentation (CAL/UAL), C&R file completion and C&R responses.
  • Manage document translation when needed.
  • Provide evidence for followup and closure inquiries for reportable C&R required by Competent Authorities and or other regulatory agency as required by Country/Market.

In return, we offer you
Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.

How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers.

We are embracing an approach wherein we spend more time together than apart - which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home - for our hybrid roles.

Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:

  • We believe in the importance of impactful collaboration:_ There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.
  • We embrace flexibility:_ Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn't office or online, it means choosing the space that works best for you, your teams and our customers on a casebycase basis.
  • We want to be at our best:_ The way we work and our workspaces are designed to support our wellbeing, offer career advancement o

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