Philips Post Market Surveillance C & R Engineer 

South Africa, Free State, Dihlabeng Local Municipality 

602220358

Post Market Surveillance, C&R Engineer

Your role:

• Executing post-market product data analysis processes in support of Product Quality Safety Surveillance Data Review and providing post-market surveillance data in support of regulatory health authority requests, root cause investigations, and new product development.

• Ensuring the adequacy of the documentation of post-market surveillance activities in terms of regulatory compliance and technical/statistical soundness, presents results and proposes escalations, corrective, and preventative actions as required. Collaborates and interacts with internal teams, including teams representing Medical, R&D, Product Quality, Engineering and Supplier Quality. Regularly interacts with executive management.

• Reviews and continuously executes the global post-market surveillance process. Extracts monthly post-market quality data and maintains compliant records. Performs post-market safety and surveillance activities including data analysis, tracking/trending, and signal detection.

• Evaluates Safety Signals through data analytics, adverse event reporting, Non-Conformance Reports, Corrective Actions/Preventative Actions, Customer Feedback. Responsible for summarizing trends, signals, and escalations.

• Executes filing of appropriate post-market, safety surveillance-related submissions and reports to regulatory agencies worldwide in accordance with Quality System procedures. Completes projects/other duties as assigned. Provides support during external and internal audits of the post-market surveillance processes.

You're the right fit if:

• You’ve acquired 7+ years of medical device and/or other regulated industry (pharma, IVD) experience.

• Your skills include 1+ years of experience with data analytics or computer science and at least a Bachelor's degree in a science or engineering discipline.

• You have 1+ years of experience with CAPA, as well as global medical device regulations and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

• 1+ years of experience with quality systems, quality tools and methodologies, including Critical to Quality, FMEA, Root Cause Analysis, Pareto, 8-D, 5 Why, Audit training, skills, or willingness to learn experience with auditing suppliers.

How we work together

This is an office role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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The pay range for this position in Massachusetts is $89,376 to $153,216

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.