Staff Quality Engineer, Complaint Handling / Post Market Surveillance #4836

Quality Management System Role

This position is a key individual contributor in the Sustaining and Post Market Quality organization, responsible for executing, maintaining, and improving the Sustaining and Post Market Quality elements of GRAIL's quality management system (QMS). This position interacts with departments throughout the organization including but not limited to all-Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs, Compliance, Program Management, Clinical Affairs, Supply Chain, Manufacturing, and Research & Development. The person in this role consistently applies critical thinking skills and good judgment to proactively identify and solve complex problems, effectively communicating status and recommendations to management.

Primary responsibilities include facilitating and supporting Complaint Handling/Post Market Surveillance. This individual contributes to a positive environment of accountability and performance excellence. This individual may represent the Quality organization during audits and inspections as well as on various project teams as determined by management.

This role is based at our Durham, North Carolina, office and offers a flexible working arrangement. It offers a flexible work arrangement, with the ability to work from GRAIL's office or from home. Our current flexible work arrangement policy requires that a minimum of 60%, or 24 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with team and business needs and could exceed the 60% requirement for the site.

Responsibilities:

• 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 the Complaint Handling/Post Market Surveillance Program, 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 regulations and standards.
• Lead and support quality system process improvements, workflow implementations, and system configurations associated with the Complaint Handling/PMS Program.
• Generate and maintain post market surveillance plans and reports.
• Partner with GRAIL Customer Service Team and Medical Information Team to facilitate feedback evaluation, complaint investigations and closure across all GRAIL sites. Perform assessments for reportability on adverse events, impact/risk, and trend analysis.
• Provide Quality oversight, including review, feedback, and approval for Complaint Handling/PMS Programs.
• Respond to all inbound complaint related inquiries and maintain effective cross-functional team communications to advance GRAIL's quality activities and promote standard methodologies.
• 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, ISO 14971, IVDR, ISO 15189, 21 CFR Part 493 (CLIA), CAP, New York State Department of Health (NYSDOH), and related regulations and standards.
• Represent complaint handling/PMS 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.
• These responsibilities summarize the role's primary responsibilities and are not an exhaustive list. They may change at the company's discretion.

Required Qualifications:

• Degree in science, engineering, or other technical area, or equivalent experience.
• Minimum of 8 years of experience working within a medical device, pharmaceutical, or biotech quality management system, with at least 4 years direct involvement in administering Complaint Handling/Post Market Surveillance Programs.
• Experience using an eQMS
• 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.

Preferred Qualifications:

• Experience using an eQMS, preferably Veeva Quality Suites.
• Excellent written and verbal communication skills.
• Proficiency with standard office software applications including Microsoft Office, Google Suite, and Zoom

Physical Demands and Work Environment:

• Work is performed in office, laboratory, and production environments.
• May involve occasional lifting of up to 25 lbs. and extended standing or walking in manufacturing areas.
• PPE such as safety glasses, gloves, or cleanroom attire required depending on assignment.
• Standard weekday schedule, with flexibility for extended hours during audits, inspections, or urgent quality issues.

The expected, full-time, annual base pay scale for this position is $118K - $154K. Actual base pay will consider skills, experience, and location.

This role may be eligible for other forms of compensation, including an annual bonus and/or incentives, subject to the terms of the applicable plans and Company discretion. This range reflects a good-faith estimate of the range that the Company reasonably expects to pay for the position upon hire; the actual compensation offered may vary depending on factors such as the candidate's qualifications. Employees in this role are also eligible for GRAIL's comprehensive and competitive benefits package, offered in accordance with our applicable plans and policies. This package currently includes flexible time-off or vacation; a 401(k) retirement plan with employer match; medical, dental, and vision coverage; and carefully selected mindfulness programs.

GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran,, or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at rc@grailbio.com if you require an accommodation to apply for an open position.

GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!