Responsibilities:
Change Control and Design:
- Lead the execution of defect management and engineering escalation processes, ensuring timely identification, resolution, and reporting of product issues.
- Drive the review and approval of design and service verification and validation protocols, with a focus on product changes and lifecycle processes.
- Manage cross-functional teams in product change control processes and ensure comprehensive documentation of product modifications.
- Take ownership of maintaining and updating the Device Master Record (DMR) for assigned product lines during post-market changes.
- Ensure alignment of design outputs with inputs, proactively addressing discrepancies and ensuring compliance with internal protocols.
- Act as the lead liaison between engineering, product management, and quality teams to integrate quality considerations early in the product design phase.
Field, Customer and Safety:
- Independently process and triage out-of-box quality issues, conducting root cause analyses and collaborating with teams to drive corrective actions.
- Lead post-production safety risk assessments and implement solutions to mitigate safety concerns.
- Drive the Medical Device Reporting (MDR) process, coordinating with regulatory bodies and managing field actions and recalls.
- Present safety and risk management updates during Safety Risk Management Board Meetings, with responsibility for product-specific risks.
Compliance and Continuous Improvement:
- Lead quality improvement projects aimed at optimizing processes, reducing defects, and enhancing customer satisfaction.
- Ensure adherence to ISO 9001, ISO 13485, and other relevant regulatory standards, acting as a subject matter expert for compliance.
- Implement and analyze quality metrics, creating reports to monitor process performance and drive data-driven improvements.
- Conduct internal audits and manage corrective and preventive actions (CAPA) to ensure continued compliance and improvement.
Required Knowledge and Skills:
- Advanced knowledge of QMS (Quality Management System) documentation and regulatory standards (ISO 9001, ISO 13485).
- Proficiency in quality investigation tools (e.g., Fishbone diagrams, 5 Whys) and statistical analysis (e.g., SPC, Six Sigma).
- Understanding of software development lifecycle (SDLC) and experience in defect tracking platforms like Jira
- Experience in leading cross-functional teams and managing product changes from initiation through post-market stages.
- Strong project management skills and the ability to manage multiple priorities effectively.
- Excellent problem-solving, communication, and leadership abilities.
Basic Qualifications:
- Bachelor's degree in Engineering or Science discipline
- 5+ years in Engineering, Quality or related technical professional experience
- Experience in product development and/or maintenance
- Experience in process development
- Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA QMSR)
Preferred Qualifications:
- Experience working with complex electro-mechanical systems
- Experience working with Cloud software and AI/ML
Work Conditions:
- Office Environment
- May travel up to 25%