Senior Quality Engineer, Complaint Handling

Role Overview

• Support Quality Operations through expert interpretation, establishment, and execution of quality concepts and principles in accordance with GRAIL’s quality management system and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ISO 15189, and related regulations and standards.
• Use proactive, creative problem-solving to contribute to development of concepts and principles to achieve goals and objectives.
• Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought.
• Exercise excellent judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Act independently to determine methods and procedures to successfully complete assignments.
• Structure day-to-day work autonomously, effectively communicating status and issues with management.
• Identify and evaluate deficiencies and improvement opportunities, working cross functionally to resolve and improve on existing processes.
• Create and support a quality culture by driving compliance activities around Complaint Handling and Post Market Surveillance Programs, partnering across the organization to manage continuous process/quality improvements that strongly align with GRAIL procedures and customer (internal and external) needs while meeting all applicable Medical Device Regulations and Standards.
• Support continuous quality system process improvements, workflow implementations, and system configurations associated with Complaint Handling and PMS Programs.
• Partner with GRAIL Customer Service, Medical Information, Clinical Surveillance to facilitate feedback evaluation, complaint investigations and closure across all GRAIL sites. Perform assessments for reportability on adverse events, impact/risk, and trend analysis.
• Evaluate and identify areas of non-compliance, risk and/or potential improvement to management and develop plans for appropriate action to address causes of deficiencies.
• Provide Quality review, feedback, and approval for Complaint Handling and PMS Programs.
• Respond to all inbound, complaints and post-market risk management related inquiries and maintain effective cross-functional team communications to advance GRAIL’s quality activities and promote standard methodologies.
• Generate and maintain post market surveillance plans and reports.
• Facilitate timely and effective clinical lab-related NCRS, CAPAS, planned deviations, validations, and change control workflows related to Complaint Handling/Post Market Surveillance.
• Support generation of Quality Systems metrics, which roll up to Quality Indices and Key Performance Indicators, and Quality Management Review.
• Cultivate positive relationships with key partners, leadership team members, and other cross-functional partners throughout GRAIL, including third-party vendors/consultants.
• Implement programs to comply with all applicable regulatory requirements including 21 CFR 820, ISO 13485, and ISO 14971, IVDR, ISO 15189, 21 CFR Part 493 (CLIA), CAP, New York State Department of Health (NYSDOH), and related regulations and standards.
• Represent Quality Operations on sanctioned cross-functional projects driving toward effective, on-time completion of business goals and objectives.
• Drive a culture of quality across the organization with the goals of efficiency, compliance, and continual improvement.

Requirements

• Bachelor’s degree in science, engineering, or other technical area.
• 5+ years of experience working within a medical device, pharmaceutical, or biotech quality management system.
• Working knowledge and understanding of regulations and standards, including but not limited to QSR, ISO 13485, Quality System, CAP/CLIA, NYS, ISO 15189 and other applicable industry requirements.
• Proven ability to efficiently manage workload under tight deadlines and pressure in a composed manner.
• Demonstrated ability to perform meticulous work with a high degree of accuracy and completeness.
• Demonstrated project management experience developing processes and leading their implementation in a cross functional environment.
• Experience supporting regulatory inspections/audits and responding to findings.
• Excellent written and verbal communication skills.

Benefits

• flexible time-off or vacation
• a 401(k) retirement plan with employer match
• medical, dental, and vision coverage
• carefully selected mindfulness programs