Job Title Risk Management Engineer
Job Description
Risk Management Engineer
In this role, you have the opportunity to make life better
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.
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:
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5+ years working knowledge of ISO 14971 and product specific regulations and standards. 3+ years working experience in a regulated industry.
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Ensures product safety risk management deliverables are created, maintained, and stored in the Risk Management file during product development.
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Ensures the appropriate safety risk assessments are performed when triggers are met and conducts product risk assessments as needed after product launch.
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Defend Risk Management and design quality activities during external and internal audits.
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Perform periodic reviews of Risk Management Files and ensure those are performed according to schedule.
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Evaluate process and product changes for their impact on the current Risk Management Files.
Responsibility #2:
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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
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Coordinates with a cross functional team including Engineering and Medical Affairs in the creation and maintenance of the deliverables listed above.
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Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
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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:
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Introduce and implement complaint handling processes and tools required to ensure global regulatory compliance, quality, and patient safety.
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Manages compliance to FDA regulations and other Regulatory Agencies as required.
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Manages the oversight and review of complaint handling files, adverse event reports, regulatory inquiry responses, and safety escalations.
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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:
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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.
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Provides expert consultation to individuals responsible for the coordination and preparation of responses to regulators and competent authority inquiries when needed.
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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.
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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:
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Develops and presents materials describing complaint handling and regulatory reporting KPIs, metrics, and/or daily management information to business, market, and leadership.
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Facilitates conversations with technical experts to ensure timely completion of escalations. (Technical investigations, IIAs, CAPAs)
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:
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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.
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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.
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Product Knowledge is preferred. Project Management certificates(preferred).
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Mandatory: Working Knowledge in the area of Complaint Handling, Vigilance reporting and its global timelines and Post Market Surveillance (PMS) for medical products.
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Preferable: Knowledge of software product development, knowledge in Trackwise tool and/or Service tools. Knowledge of analytics tool/KPI trackers/Daily managements etc..
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Detailed oriented, work allocation and monitoring, good communication skills, mentoring, team management, conflict management, team dynamics, self-starter, results, and targets oriented, resilience.
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A dvanced English required (Oral and Writing)
