Risk Management Engineer

Job Title

Risk Management Engineer

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

Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So in this role of Complaint Investigator, you share our passion for helping others, you’ll be working towards improving people’s live by improving product and patient safety.

You are responsible for:

·

Responsibility #1:

• 5+ years working knowledge of ISO 14971 and product specific regulations and standards. 3+ years working experience in a regulated industry.

• Ensures product safety risk management deliverables are created, maintained, and stored in the Risk Management file during product development.

• Ensures the appropriate safety risk assessments are performed when triggers are met and conducts product risk assessments as needed after product launch.

• Defend Risk Management and design quality activities during external and internal audits.

• Perform periodic reviews of Risk Management Files and ensure those are performed according to schedule.

• Evaluate process and product changes for their impact on the current Risk Management Files.

Responsibility #2:

• Monitor post product data (e.g. Complaints, Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCRs), Customer Feedback information, etc.) for impact to the Risk Management Files

• Coordinates with a cross functional team including Engineering and Medical Affairs in the creation and maintenance of the deliverables listed above.

• Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.

• Ensures that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business.

· Responsibility #3:

• Introduce and implement complaint handling processes and tools required to ensure global regulatory compliance, quality, and patient safety.

• Manages compliance to FDA regulations and other Regulatory Agencies as required.

• Manages the oversight and review of complaint handling files, adverse event reports, regulatory inquiry responses, and safety escalations.

• Actively participates in inspections and questions relating to the operation of complaint handling operations, processes, and procedures in coordination with all other applicable company groups.

· Responsibility #4:

• Communicates performance feedback to individuals performing complaint handling activities, ensuring consistency, quality, and adherence to defined processes related to complaint handling, adverse event reporting, and safety escalations.

• Provides expert consultation to individuals responsible for the coordination and preparation of responses to regulators and competent authority inquiries when needed.

• Provides expert consultation and communicates decision making related to escalated issues for complaint handling activities, regulatory reporting decisions, requirements for additional investigation, and subject matter expert engagement.

• Engages with individuals within the Businesses, Markets, and Services organization to ensure the required information for complaint handling, regulatory reporting, and/or escalations for further investigation or action are communicated and acted upon.

· Responsibility #5:

• Develops and presents materials describing complaint handling and regulatory reporting KPIs, metrics, and/or daily management information to business, market, and leadership.

• Facilitates conversations with technical experts to ensure timely completion of escalations. (Technical investigations, IIAs, CAPAs)

• Support audits for complaint handling

You will be part of

You will be part of the Quality Team in Electronic Medical Records & Care Management Business. You will be able to partner with other experienced Quality team members and Leadership that will support you in the upcoming challenges and goals, and you will be able to join a very organized area where the teamwork is very much valued.

To succeed in this position, you need to have the following expertise and experience:

• Bachelor degree in bio-medical, engineering, healthcare, or related technical degree with 8+ years of experience; OR Bachelor degree with 8+ years of experience in a medical device or regulated industry.

• 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), EUMDR, Canadian Medical Devices Regulation (SOR/98- 282), Japanese MHLW Ordinance 169, and ISO 9001. ISO14971 Risk Management, CAPA, Previous experience in Medical device.

• Product Knowledge is preferred. Project Management certificates(preferred).

• Mandatory: Working Knowledge in the area of Complaint Handling, Vigilance reporting and its global timelines and Post Market Surveillance (PMS) for medical products.

• Preferable: Knowledge of software product development, knowledge in Trackwise tool and/or Service tools. Knowledge of analytics tool/KPI trackers/Daily managements etc..

• Detailed oriented, work allocation and monitoring, good communication skills, mentoring, team management, conflict management, team dynamics, self-starter, results, and targets oriented, resilience.

• A dvanced English required (Oral and Writing)

In return, we offer you

At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2030, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy, respiratory care and services.

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.