In this role, the Software Quality Engineer for the Revvity Omics Clinical Laboratories will provide support to Laboratory Directors, Bioinformatics, Information Technology (IT) and related personnel on software and data quality related matters. S/he will work with the Sr. Director, Quality Assurance to develop, implement, execute, and maintain policies and procedures as well as training and education programs, with an emphasis on software development, software implementation, and data related concerns such as security, storage and destruction. This role requires performing internal and external audits, as well as developing and maintaining required documentation and quality metrics. S/he will participate in quality meetings. A strong candidate for this position will be able to maintain good rapport and communication with leadership and team members while ensuring solid execution of quality programs.
Duties and Responsibilities:
Provide advice and support to the Laboratory Directors, Bioinformatics, Information Technology (IT), Quality Manager and testing personnel on software and data quality issues
Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements with an emphasis on software and data related items
Understand the Document Control System (PolicyTech) to ensure SOPs, Trainings and Policies are current versions and assigned appropriately. Notify Department leaders of employee signoffs not completed within deadlines
Assist in the review of SOPs, validations, and incident reports with emphasis on software and data related items to ensure they meet Quality standards and adhere to company guidelines
Participate in the maintenance of laboratory licensure as required by CLIA, CAP and other regulatory bodies
Quality assurance and control of laboratory performance through internal and external audits
Training & Education: Assist with training and education programs, to educate employees and management on quality processes, standards, and results
Project Management: Participate in the planning, initiation, and management of quality improvement projects
Lead and implement various product and process improvement methodologies
Maintain good communication with leadership, team members and customers
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Data privacy and security, and other regulatory requirements
Familiarity with operation of laboratory instruments and applicable computer software and data
Other duties as assigned
Basic Qualifications:
Bachelor of Computer Science or related degree
Minimum 3 years of experience in clinical / healthcare quality management
Demonstrated experience with Quality Assurance and Quality Control of software and data
Preferred Qualifications:
Knowledge of clinical laboratory, clinical trial and / or life science manufacturing software and data requirements
Experience with healthcare data privacy and protection requirements
Able to partner and work collaboratively with laboratory operations staff
Proven track record of delivering continual positive process improvement in systems and process
Proven leadership and excellent organization and communication skills
A good balance of negotiating and influencing skills
Excellent presentation skills
Be detail oriented, organized, with excellent verbal and written communication skills
Able to work effectively and able to deliver on tight datelines
Comfortable working in a fast-paced environment
Working Conditions: (describe office, lab environment, include shifts and any travel)
This position on-site preferred with remote considered; must be able to work with computer, screen, and keyboard for majority of time
A professional work environment that is private, free of distraction, and with limited background noise must be maintained.
Video and voice calls are required
Travel of 0 - 10% of time
Physical Requirements:
While performing the duties of this job, the employee is regularly required to sit, stand, and use a keyboard, type
Reach above/below the shoulder, bend at the knees and waist
