Quality Director- Costa Rica Site Quality Leader

hace 1 semana

Alajuela, Costa Rica Philips A tiempo completo

**Job Title**: Quality Director
- Costa Rica Site Quality Leader

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.

The Director of Quality Operations at Philips Costa Rica is responsible for all aspects of quality manufacturing, complaint investigations, quality warehousing, acceptance activities, microbiology, and quality assurance activities.

Position Summary

Responsible for quality operations at Philips Costa Rica including but not limited to receiving and final inspection teams, compliance, quality engineering, microbiology, site sterility assurance and leading and developing quality team. Serves as the Management Representative and Management Team Member for the site. This position requires a seasoned quality professional in FDA regulatory industry with a proven track record in change management and people development.

**Responsibilities**
- Supervise quality team supporting the manufacturing and warehousing facility, including but not limited to acceptance activities, manufacturing, complaint investigations, labeling, packaging, sterilization and microbiology.
- Provide direction and partner with cross functional team in root cause analysis and issue resolution related to manufacturing, quality management systems, and compliance.
- Optimize procedures and work instructions a part of continuous improvements to the quality management system.
- As needed, review and approve procedures, work instruction, protocols, reports for the manufacturing site, including but not limited to process validation and equipment qualifications.
- Partner with manufacturing and supply chain in product quality improvements, including but not limited to product yield and Cost of Non-Quality measures.
- Oversee tracking and trending of the site’s quality performance data and provide direction on issue resolution for negative trends and results.
- Partner with Business and Operation team members in product transfers, new product development and continuous improvement projects
- Establishes and manages the necessary quality programs to ensure the Company meets the Quality System requirements per company procedures and applicable federal regulations and international standards
- Work with cross functional team on operations quality mentorship programs, development and succession planning
- Submit and manager quality budget in accordance with Philips requirements

**Experience/ Qualifications**
- Bachelors or master’s degree required, Engineering or Science preferred
- 10+ years in FDA regulatory industry required (Medical Devices, Pharmaceutical, Aerospace, or combination thereof)
- 7 years in Quality required; and 6+ years of management level experience required.
- CQE, CBA, or CQA are preferred
- Must have demonstrated ability to work with senior/executive leaders and be able to engage/influence cross functional leadership teams
- ** Onsite**

**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.

**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.

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