What are the responsibilities and job description for the DCRM QMS Risk Management Engineer position at Katalyst HealthCares & Life Sciences?
Responsibilities
- Lead/Support continuous improvement initiatives for design control and risk management processes.
- Identify and eliminate process inefficiencies using operational excellence tools.
- Develop training materials to foster a culture of operational excellence.
- Ensure processes align with regulatory requirements for medical device and drug combination products (e.g. FDA 21 CFR Part 820, ISO 13485, ISO 14971).
- Collaborate with cross-function teams to improve processes related to device-drug integration.
- Partner with Quality and Regulatory teams to ensure compliance with applicable global regulations.
- Leverage data analytics and key performance indicators to monitor process performance.
- Proven ability to work with team members of diverse skill sets and backgrounds.
- Strong analytical and problem-solving abilities.
- Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership.
- Excellent communication, presentation, negotiation, project management, and organizational skills.
- B.A./B.S. in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus 7 years of related experience or Master's degree in one of the above disciplines plus 5 years related experience.
- 5 years of experience in process improvement, Quality management system, operational excellence.
- Has broad knowledge of medical device development, design controls and risk management.
- Hands-on experience with combination products.
- Proven track record of driving lean and six sigma initiatives in a regulated environment.
- Led and managed development of DHF (design history file) deliverables for medical devices.
- Knowledge of U.S. and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.
- Self-motivated and work independently.
- PMP or similar project management certification.
- Quality Engineering Certification.
- Six Sigma Certification.
- Experience with device design, requirement management, FMEA, design verification, design validation, statistical sampling, and control strategy.
