Quality Compliance Specialist

hace 1 semana

Alajuela, Costa Rica Philips A tiempo completo

**Job Title**: Quality Compliance Specialist

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**
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

**Responsibilities**
- Participates of the external audit team and work on the logistics and preparation.
- Prepare metrics and compliance information for the site to be send to Management.
- Performs timely, detailed, and independent internal Quality

Management System (QMS) and product-focused audits to assess regulatory compliance to applicable local and international regulations/standards and Philips requirements.
- Lead or assist on the backroom and front room teams for EA.
- Provide support, including reviewing responses to audit findings, CAPA evaluation/investigation for

completeness and effectiveness.
- Identifies and shares “Best Practices” within Philips.

**You are a part of**

IA/MR Compliance Specialist will manage the Internal Audit Program and Management Review locally, including preparation of metrics for Management Review and report out of the Quality System Trending.

**Requirements**:

- Bachelor’s degree, or a combination of equivalent job experience in related field.
- 1+ years of experience in a **medical device, IVD, biologics or Pharma industry.**:

- At least 1 year of experience in CAPA's program management
- Advanced English level
- Analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.
- Ability to work under pressure
- Excellent verbal / written communication, interpersonal, and organizational skills; must be able to multi-task, assimilate, and analyze information quickly.
- Ability to organize and prioritize workflow and to meet established timeframes
- impact and influence
- Teamwork
- Audit program experience is a plus
- Hybrid Schedule

**In return, we offer you**
The opportunity to work in a multi modal Site with 4 different Business Units, and different technologies, which mean a learning experience for any professional looking forward to keep growing in the Medical Devices Industry.

Interaction and teamwork with external parties.

**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 case-by-case basis.
- We want to be at our best:_ The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

**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.

LI-PH1

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