Senior Quality Engineer

hace 2 semanas

Alajuela, Costa Rica Philips A tiempo completo

**Job Title**:
Senior Quality Engineer - Operations

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.

**You are responsible for**

The QE, Manufacturing Operations, promotes and implements organizational policies & standards to ensure product quality through design transfer, manufacturing and distribution, in compliance with regulatory requirements and Philips' Business Systems/procedures.
- Establish and implement global Process Quality Engineering policies/ standards/ practices at the Single Value Added Layer (SVAL) level in scope for Manufacturing / Operations.
- Implement and provide oversight of consistent global Q&R requirements related to nonconformance handling, risk evaluation, control plans, environmental controls, validation / re-validation after changes for medical and non-medical products.
- Provide Q&R oversight on Operations projects ensuring timely completion and appropriate quality of project deliverables.
- Frequently interact with functional peers and upper management normally involving Manufacturing and Operational matters between functional areas, other Business Groups / Units, or customers.
- Seasoned experienced professional with a full understanding of manufacturing and operations, resolving a wide range of issues in creative ways, including the introduction of new concepts.
- Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
- Strong leadership skills and demonstrated ability to influence change and challenge status quo with respect to opportunities for improvement.
- Ability to manage competing priorities in a fast-paced environment.
- Serves as best practice/quality resource within own discipline or as technical expert on functional or cross-functional teams or projects.

**You are a part of**

A leading health technology company with a multinational workforce of approximately 77,000 employees and globally present with sales and services in more than 100 countries worldwide.

**To succeed in this role, you’ll need a customer-first attitude and the following**
- 3 years of experience in a medical device or regulated industry.
- BS in relevant field including Quality Management, Manufacturing, or Engineering and / or relevant business experience preferred.
- Strong knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge).
- DMAIC, 8D, PRIDE and other problem solving and analytical skills.
- Excellent technical, writing and communication skills and interpersonal relationship skills including negotiating and relationship management skills.
- Identifies technical gaps and takes action to address them.
- Prior experience with large and complex quality continuous improvement programs and projects, with demonstrated success and impact on quality KPI’s.- Data-driven decision-making and the ability to move teams through vague and complex situations to develop clearly defined programs

**In return, we offer you**

In order to develop your full potential, we will offer you the flexibility, encouragement and opportunities to keep you inspired and engaged. After all, working at Philips is more than a job. It is an experience full of amazing moments that will transform you in a lasting and positive way, since together we can improve the world.

**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. For our hybrid roles, this translates to an average of three days working from the office and two days f

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