What are the responsibilities and job description for the Quality Engineer position at Katalyst HealthCares and Life Sciences?
Risk Management Expert:
Collaborate at a systems level with cross-functional teams to develop a quantitative approach to risk management, leading the way in regulatory compliance and product safety.
Key Responsibilities:
Requirements:
Collaborate at a systems level with cross-functional teams to develop a quantitative approach to risk management, leading the way in regulatory compliance and product safety.
Key Responsibilities:
- Foster collaboration between R&D, Clinical, Data Analysis, and other key functions to drive innovative risk management solutions.
- Lead cross-functional teams to identify risks, implement control measures, and document a robust Risk Management File, ensuring seamless communication and cultural change.
- Facilitate creation of top-down and bottom-up risk management tools, assessments, processes, and principles, including FMEAs, to stay ahead in the industry.
- Analyze existing products from our company and competitors to provide documented evidence of State of the Art, as part of periodic risk management file updates.
- Ensure products meet stringent regulatory requirements, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures.
- Guarantee systematic conversion of customer requirements to product specifications and post-surveillance codes, fostering reliability and repeatability.
- Create and continually improve procedures and work instructions to ensure ongoing compliance improvement initiatives, including CAPAs across five business groups in Connected Care.
Requirements:
- Bachelor's degree in Engineering or related field; Master's preferred.
- 6 years of experience in Quality Assurance, Design Engineering, Systems Engineering, Post-Market Surveillance, or related fields in highly regulated industries.
- Extensive hands-on experience with ISO 14971 standard and knowledge of 21 CFR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards.
- Strong understanding of risk management requirements, tools, methodologies, and processes, including variety of accepted methods.
- Demonstrated expertise in managing complex projects and implementing cultural change.
- Excellent customer service and interpersonal communication skills, including presenting regularly to peers and leadership.
- Experience working within Quality Management System.
- Green Belt or Black Belt certification preferred.
- Outstanding teamwork skills, influencing and building rapport with internal customers and stakeholders.
