Lumicity Ithaca , NY 14850
Posted 1 week ago
Key Responsibilities:
Develop, implement, and maintain quality management systems in compliance with ISO 13485, FDA regulations, and other relevant standards.
Conduct risk assessments and failure mode and effects analyses (FMEA) for new and existing products.
Perform root cause analysis and implement corrective and preventive actions (CAPA) for quality issues.
Review and approve design verification and validation protocols and reports.
Support the development and execution of product testing and inspection procedures.
Ensure proper documentation and record-keeping for all quality processes and activities.
Conduct internal and supplier audits to ensure compliance with quality standards.
Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure product quality and compliance.
Provide quality engineering support during new product development and introduction.
Participate in continuous improvement initiatives to enhance product quality and process efficiency.
Qualifications:
Bachelor's degree in engineering, biomedical engineering, or a related field.
Minimum of 3-5 years of experience in quality engineering within the medical device industry.
Strong knowledge of ISO 13485, FDA QSR, and other relevant regulations and standards.
Experience with risk management processes, including FMEA and CAPA.
Proficient in quality management systems and tools.
Excellent problem-solving, analytical, and communication skills.
Ability to work effectively in a team environment and manage multiple projects simultaneously.
Certified Quality Engineer (CQE) or equivalent certification is a plus.
Lumicity