GRAIL
Healthcare
StaffQualityEngineer,ComplaintHandling/PostMarketSurveillance
“Staff Quality Engineer, Complaint Handling / Post Market Surveillance at GRAIL. Skills: Complaint Handling, Post Market Surveillance, Quality Management System, Regulatory Compliance. Support Quality Operations. Interpret quality concepts”
Industry & Context.
Problem-solving; Creative problem-solving
Occasional lifting up to 25 lbs, Extended standing, Extended walking, PPE required, Flexibility for extended hours
What They're Looking For.
Must Have
Degree in science or technical area, Equivalent experience, 8+ years quality management system experience, 4+ years Complaint Handling/PMS experience, Experience using an eQMS, Working knowledge of QSR, Working knowledge of ISO 13485, Working knowledge of Quality System, Working knowledge of CAP/CLIA, Working knowledge of NYS, Working knowledge of ISO 15189, Manage workload under deadlines, Perform meticulous work, Project management experience, Experience supporting regulatory inspections
Nice to Have
Veeva Quality Suites experience, Excellent written communication skills, Excellent verbal communication skills
What You'll Do.
Support Quality Operations
Interpret quality concepts
Establish quality concepts
Execute quality concepts
Contribute to development of concepts
Contribute to development of principles
Select evaluation criteria
Structure day-to-day work
Identify deficiencies
Evaluate deficiencies
Identify improvement opportunities
Evaluate improvement opportunities
Improve existing processes
Create quality culture
Support compliance activities
Drive compliance activities
Partner across organization
Manage continuous process improvements
Manage quality improvements
Lead quality system process improvements
Support quality system process improvements
Generate post market surveillance plans
Maintain post market surveillance plans
Generate post market surveillance reports
Maintain post market surveillance reports
Partner with Customer Service Team
Partner with Medical Information Team
Facilitate feedback evaluation
Facilitate complaint investigations
Facilitate complaint closure
Perform assessments for reportability
Perform impact assessments
Perform risk assessments
Perform trend analysis
Provide Quality oversight
Review complaint handling programs
Approve complaint handling programs
Respond to complaint inquiries
Maintain cross-functional team communications
Advance quality activities
Promote standard methodologies
Support metrics generation
Cultivate positive relationships
Represent complaint handling/PMS
Drive culture of quality
Meet business objectives
How You'll Work.
Team & Collaboration
Cross functional teams; Cross-functional projects; Key partners; Leadership team; Third-party vendors; Third-party consultants
Communication Scope
Written communication; Verbal communication
Process & Methodology
Project management, Process development, Cross functional implementation
Applying for this Staff Quality Engineer, Complaint Handling / Post Market Surveillance role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Lever
- Lever uses a streamlined one-page form — apply in under 5 minutes.
- LinkedIn import works well; review parsed data before submitting.
- The cover letter field is optional but visible to reviewers — use it to differentiate.
- Referral codes from employees can significantly boost visibility of your application.
ANONYMOUS · UNFILTERED
What do employees actually say about GRAIL?
Real rants from real employees. Read before you apply.