Senior Quality Systems Engineer # 4465

Responsibilities:

• Ensure compliance with company processes and procedures, as well as applicable FDA QSR, IVDD/IVDR, ISO, CAP/CLIA, and NYS regulations and/or guidelines.
• Responsible for the oversight and continuous improvement of efficient, effective, and compliant processes supporting GRAIL’s electronic Quality Management System (eQMS) and Learning Management System.
• Lead continuous quality system process improvements, workflow implementations, and system configurations associated with the Change Management program, encompassing Document Control, Change Control, and Quality Training.
• Create and lead educational presentations on change management programs (new hire, process updates, etc.)Maintain controlled documents, track document change management processes, and edit documents to ensure formatting, legibility, completeness, and adherence to GRAIL’s controlled templates, procedures, and other relevant processes.
• Coordinate the review, approval, and archival of GRAIL’s controlled documents in accordance with strict timelines as well as internal policies and regulations.
• Collaborate and provide mentorship to change owners, approvers, and cross-functional owners, ensuring effective implementation of change. Call out areas of non-compliance, risk and/or potential improvement to management and develop plans for appropriate action to address causes of deficiencies.
• Respond to all inbound document-related inquiries and maintain effective cross-functional team communications to advance GRAIL’s quality activities and promote standard methodologies.
• Address, respond-to, and complete NCRs, CAPAs, and Internal/External Audit Findings associated with document management needs and gaps.  Generate data for key performance indicators (KPIs)/metrics for management reviews.
• Provide document control support for internal and external audits and inspections.
• Assist the Quality Systems Software Business Owner/SME with validation and configuration maintenance/improvements, including testing for system implementations and updating documents (SOPs, reports, protocols, specifications, etc.), as well as documenting, assessing, and resolving feedback to improve the end user experience, as needed.
• Cultivate positive relationships with key partners, leadership team members, and other cross-functional partners throughout GRAIL, including third-party vendors/consultants.
• Assess unusual circumstances and use sophisticated analytical and problem solving techniques to identify causes. Resolve a wide range of issues in creative but compliant ways and suggest variations in approach. 

Required Qualifications:

• Bachelor’s degree and experience developing, implementing and leading quality or regulatory activities or equivalent knowledge or experience.
• 5+  years of experience performing a quality management function, preferably with experience in Document and Records Management.
• Working knowledge and understanding of regulations and standards, including but not limited to QSR, ISO 13485 Quality System, CAP/CLIA, NYS, ISO 15189, ISO 13485, IVDR, and other applicable industry requirements.
• Experience using an eDMS required; Veeva Vault highly preferred.
• 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.
• Requires exceptional interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Comfortable in a fast-paced environment with minimal direction and able to be flexible.
• Demonstrated project management experience developing processes and leading their implementation in a cross-functional environment.
• Ability to adapt to changes in the work environment; manages competing demands; changes approach or method to best fit the situation.
• Ability to deal with frequent change, delays, or unexpected events
• Experience with auditing and experience representing and responding to regulatory agency audits.

Preferred Qualifications:

• Proficiency with standard office software applications including Microsoft Office, Google Suite, Jira, and Zoom
• Working experience in technical writing is appreciated.