What will you do
Provides quality support for sustaining and new product development activities of medical device products. Ensure that all applicable regulatory standards and directives are applied and managed in Draeger Medical Systems Incorporated (DMSI)
As a Quality Assurance representative on project teams, ensure the cross-functional teams follow design controls requirements and internal procedures/standards.
Review and approve design control documentation in accordance with defined procedures. Ensure results demonstrate compliance to medical device standards and established customer and technical requirements
Support product risk management and security requirements in accordance with applicable standards, regulations and guidance.
Support implementation of design changes, including new product introduction. Serve as the authorized Quality Assurance approver of changes.
Provide quality engineering expertise to maintain and improve product quality by investigating customer complaints. Prepare Health Hazard Evaluation when appropriate.
Review technical publications, articles, and abstracts to stay abreast of technical developments in industry and the regulatory landscape
Monitor and improve Quality Management reporting systems to meet US region and business unit requirements while maintaining consistency with global Draeger Medical systems. Communicate this information to local and global management
Work with Cross-Functional Teams to ensure QA and RA objectives are understood and achieved. Additionally, ensure that escalations are resolved in a timely manner.
Maintain compliance and continuously improve the QMS regarding ISO 9001, ISO 13485, and CFR 21 and further regulatory requirements which apply to the facility.
Take responsibility for individual CAPA's and provide input into CAPA's as appropriate. May facilitate the CAPA program for a particular product/project
Support all third-party inspections and audits (NB, FDA, etc),
Performs other duties as needed and assigned.Who you are
BS in related technical discipline
- 5-7 years of medical device product experience related product development and Quality System Management.
- Strong working knowledge of risk management and design controls for medical device products.
- Skilled in test plan development and root cause failure analysis
- Working knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 9001, ISO 13485, MDR
- Must possess effective written, verbal and presentation skills; strong influencing skills at all levels
- Skilled in statistical methods and design of experiments
- Experience utilizing standard root cause analysis tools (5-WHY, FTS, fishbone diagrams, etc.)
- Manufacturing engineering or manufacturing quality engineering experience a plus
- Certified Quality Engineering and/or Certified Software Quality Engineering certificate desired
- Familiarity with data analytics development and deployment
- Experience using electronic quality management systems software systems
Internal Code - #LI-MC1 *MON*