Manager, Quality Systems

Manage the quality management system and regulatory requirements for Quest Diagnostics to comply with all applicable regulations and standards including but not limited to FDA, ISO, as well as Federal, State, and local agencies.  Supports corporate goals and business growth.

• Ensures that the quality management system demonstrates regulatory compliance per QSR, ISO, and other applicable regulations.
• Train internal/external staff on quality management system requirements
• Prepare management representative meeting data/presentation and may be assigned management representative for assigned facility.
• Work closely with other department staff members to assist with CAPA assignments and ensure compliance of FDA, ISO and various regulatory requirements.
• Follows corporate policies and procedures.
• Manage complaint system (review, process, investigate and close complaints in timely manner, hold meetings, trend quality data, etc.) and post-market incident activities
• Manage post-market incident activities (field action, MDRs, EU/Canadian incident decision/reporting, field failure trending)
• Assess risk related to complaint and post-market activities.
• Sit on R&D project team meetings as the quality representative and assist/train R&D team in Design control documentation including risk management activities
• Trend Quality data. Monitor trends and create reports for management review
• Coordinate, manage and follow-up on quality projects
• Conduct/participate in quality audits (internal and external) and regulatory authority inspections to ensure risk to company is minimized.
• Ensure appropriate design control documentation is developed and design history file is maintained.
• Review change control documents and ascertain regulatory impact.
• Perform other duties as assigned
• Evaluate the development and deployment of testing assays for the appropriate laboratory discipline / testing category.
• Review / approval of standard operating testing procedures prior to issuance for implementation to help ensure accuracy of testing.
• Conduct pre-go-live inspections to identify and mitigate risk including but, not limited to: SOP review for practice matching procedure; review of method validation; observation of entire testing process to evaluate the robustness of the assay; appraisal of Quality Control (QC) metrics for sufficient level of      acceptability; and technologist interviews and observation on how to address assay issues for out of range QC measures (e.g., out of range QC, assay interference).
• Investigate quality issues identified within Quest Diagnostics laboratories for the appropriate laboratory discipline / testing category (e.g., quality investigations) and facilitate problem resolution.
• Act at the direction of Corporate Legal as required.
• Interface with the discipline’s Clinical Franchise to identify high-risk assays for evaluation.
• Collaborate with National Laboratory Operations and other Quest Diagnostics functions to meet desired outcomes.
• Support implementation for assays across Quest Diagnostics facilities. 
• Mediate discussions between subject matter experts regarding testing and test systems.
• Support the development and deployment of standard quality assessment policies and programs.
• Utilize quality management reports and metrics as required. (e.g. CAP, RQI, PRDP)
• Maintain knowledge of laboratory regulatory requirements, to include accrediting bodies, federal, state, and local requirements as well as Quest Diagnostics policies.
• Prepare written communications and deliver presentations as required.
• Provide technical and consultative support to Laboratory Staff and Quality Assurance Departments.
• Assist in special projects and activities as required.
• Apply the Quest Management System approach for daily work and project management.

• At least eight years successful employment in a clinical /pathology laboratory environment
• Preferred Work Experience: Experience in working effectively in an FDA-regulated environment
• Knowledge: Experience with quality management system development – required
• Skills: Communication (verbal and written), ability to build and manage an effective team, being able to influence others and drive for results, effective presentation skills, problem solving

Competencies:

• Demonstrated ability to influence and create change – required
• Strong interpersonal communication skills – required
• Demonstrated strong writing and composition skills – required
• Demonstrated success in motivating team members to reach objectives – desired
• Business Process Skills
• Able to effect Quality Improvement through problem solving skills and knowledge of quality tools – required
• Able to lead and drive change – required
• Organization skills--required
• Project and team management skills – required (Quest Management System skills – preferred)
• Analytical and problem solving skills – required
• Computer skills, including standard business software tools and typing – required
• Able to function in a matrix organization—desired
• Multi-tasking skills—desired
• Flexibility to meet continuously changing priorities and challenges
• Requires ability to understand, interpret and apply quality and regulatory requirements.

Work Environment: 

• Prolonged sitting at a desk (i.e., operating a computer, telephone use, document review)
• Walking or standing within the office area to operate other office equipment (i.e. printer / fax) or within the laboratory
• Required to wear PPE as appropriate when visiting testing locations
• Must frequently respond to text/email communications and will be required to be aware of ergonomic principles
• May be required to travel by airplane /train or drive long distances
• Ability to follow verbal or written instructions and use effective verbal and written communication

EDUCATION
Bachelor’s Degree(Required)
Master’s Degree

LICENSECERTIFICATIONS
ASCP Certification