What are the responsibilities and job description for the DCRM QMS Risk Management Engineer position at Katalyst Healthcares & Life Sciences?
Job Description
Job Description
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.
Requirements :
