Risk Management Quality Engineer (ISO14971) at APN Software Services, Inc.
Murrysville, PA
About the Job
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.,
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.,
Salary
50 - 55 /hour