What are the responsibilities and job description for the Risk Management Quality Engineer (ISO14971) position at APN Software Services, Inc.?
Title : Risk Management Quality Engineer
ID : PHIAJP00001575
Location : Murrysville, PA
Duration : 12 months
In this role, you have the opportunity to :
Be a key developer in expanding our Quality & Regulatory Risk Management team for our Sleep and Respiratory Care organization.
Create and implement new tools and methods to manage risk, contributing to the safety and efficacy of medical products that save lives and improve health.
You are responsible for :
Collaborate at a systems level with R&D, Clinical, Data Analysis, and other key functions to develop a quantitative approach to risk management.
Demonstrate expertise by leading cross-functional teams to identify risks, implement risk control measures, and document a robust and living Risk Management File.
Facilitate the creation of both top-down and bottom-up risk management tools, assessments, processes, and principles, including FMEAs.
Analyze existing similar products from the company and competitor products to provide documented compliance and evidence of State of the Art, as part of periodic risk management file updates.
Assure products meet regulatory requirements for risk management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures.
Ensure the systematic and logical conversion of customer requirements to product specifications and post market surveillance codes.
Create and continually improve procedures and work instructions to ensure reliable, repeatable results. Support ongoing compliance improvement initiatives, including CAPAs across the five business groups in Connected Care.
You are a part of :
An organization that believes what you do every day can contribute to the innovative health technologies and solutions we develop that positively impact billions of people every year. Including you.
Because you will find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways.
Our mission is to improve peoples lives through meaningful innovation.
We want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues worldwide.
To succeed in this role, you should have the following skills and experience :
BS in Engineering or a related field. MS preferred.
6 years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry.
2 years experience with a MS or higher.
Extensive hands on experience with the ISO 14971 standard.
Knowledge of 21 CR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards.
Strong understanding of risk management requirements, tools, methodologies, and processes, including use of a variety of accepted methods.
Demonstrated expertise in managing complex projects and implementing cultural change.
Excellent customer service and interpersonal communication skills, including regularly leading presentations in front of peers and leadership.
Experience working within a Quality Management System.
Green Belt or Black Belt certification preferred.
Excellent team work skills including influencing and building rapport with internal customers and stakeholders.,
Keep a pulse on the job market with advanced job matching technology.
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a Risk Management Quality Engineer (ISO14971)?
Sign up to receive alerts about other jobs on the Risk Management Quality Engineer (ISO14971) career path by checking the boxes next to the positions that interest you.
Not the job you're looking for? Here are some other Risk Management Quality Engineer (ISO14971) jobs in the Wilmerding, PA area that may be a better fit.
We don't have any other Risk Management Quality Engineer (ISO14971) jobs in the Wilmerding, PA area right now.
