Staff Quality Engineer Complaint Handling / Post Market Surveillance #4836

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 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 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.
 

What We Do

GRAIL is a healthcare company whose mission is to detect cancer early when it can be cured. GRAIL is using the power of high-intensity sequencing population-scale clinical studies and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology and to develop and commercialize pioneering products.

Why Work With Us

Everything we do is guided by our mission to detect cancer early when it can be cured. It’s the reason we’re here and it’s no small task. The right people make all the difference. That’s why we’re looking for those who strive to share their knowledge contribute their skills inspire each other and commit to something bigger than themselves.

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