GRAIL
Staff Quality Engineer, Complaint Handling / Post Market Surveillance #4836
Durham, NC · Staff+ · Full-time
Sponsorship not specified$118k-$154kDetected 49 days ago
Data ScienceProject ManagementSupply ChainCustomer SupportClinical TrialsClinical Laboratory TechniquesFDA RegulatoryNGSMedical DevicesResearchLeadershipCommunicationCollaborationProblem SolvingCritical ThinkingMicrosoft OfficeRegulatory Affairs
About the role
- GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom.
- It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.
- 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.
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.
- 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.
- 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.
- Drive a culture of quality across the organization with the goals of efficiency, compliance, and continual improvement.
- Perform assessments for reportability on adverse events, impact/risk, and trend analysis.
Requirements
- Degree in science, engineering, or other technical area, or equivalent experience.
- Demonstrated ability to perform meticulous work with a high degree of accuracy and completeness.
- Experience supporting regulatory inspections/audits and responding to findings.
- Experience using an eQMS
- Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and regular independent thought.
Nice to have
- 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.
Skills
- Actual base pay will consider skills, experience, and location.
Compensation
- The expected, full-time, annual base pay scale for this position is $118K - $154K.
Benefits
- 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 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.
- Partner with GRAIL Customer Service Team and Medical Information Team to facilitate feedback evaluation, complaint investigations and closure across all GRAIL sites.
Company info
- 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.
- GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow.
Equal opportunity
- Please contact us at rc@grailbio.com if you require an accommodation to apply for an open position.
This listing is sourced directly from GRAIL's careers page and normalized into a canonical job model.