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Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.

Position Summary

As part the Quality Assurance team at Caris Life Sciences, the Manager, CAPA & Complaints position provides quality oversight of the CAPA and Complaints Quality Assurance processes at Caris Life Sciences. Additionally, this role will manage and lead the Complaint Specialists and Quality Events Analysts. This role may also be engaged in Nonconforming Product, Internal and External Audits, Quality Planning, Management Review, and other Quality Management System functions as needed.

Job Responsibilities

• Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as intended and/or designed.

• Responsible for development of systems that review and approve of Complaints, Quality Events, Deviations, and CAPAs for completeness, accuracy, effectivity, and timeliness along with the review and approval of CAPA changes and extension requests.

• Responsible to for review and implementation of updates to Caris documents associated with applicable regulations and standards.

• Apply Risk Management standards to all CAPA system and Complaints processes.

• Work with other department management to identify opportunities for process improvement based on CAPA, Deviation, Quality Event, and Complaint metrics.

• Participate in Quality System team management meetings.

• Create reporting systems to analyze Quality reports and records to determine trends and recommend corrective and preventive action when trends have crossed actionable limits, in line with a Risk based approach QMS.

• Act as a Subject Matter Expert (SME) on all related procedures, ensuring compliance to the relevant procedures.

• Liaise with relevant functional groups to facilitate and mentor teams through all stages of the CAPA process. Lead and participate in cross-site and corporate project teams in areas of CAPA and quality system improvement.

• Ensures that effective corrective actions are implemented and contribute to Quality of Caris manufacturing and/or testing.

• Participate in Regulatory inspection readiness activities and provide support during Regulatory site inspections.

• Ensure users and CAPA team members provide necessary rigor to the CAPA system content including maintenance of a live record with all relevant evidence attached in a timely manner.

• Facilitate and coach CAPA team in the application of problem-solving techniques and promote its uses and development (e.g., human error reduction, 4-D, etc.).

• Ensure adequate training curriculum is maintained and provided to all users of CAPA process and systems.

• Accepts other duties as assigned.

Required Qualifications

• Must possess strong communication, project management and influencing skills and have the ability to manage multiple tasks simultaneously.

• BS in a Science, Engineering, or related discipline.

• 5+ years of professional work experience in a regulated production/manufacturing environment.

• Experience successfully leading event investigations, Risk Management (ISO 14971), Root Cause Analysis (RCA), and CAPA.

• Experience with ISO 13485, 21 CFR Part 820, and CAP/CLIA required.

Preferred Qualifications

• Experience supervising personnel in a quality or regulatory role.

• Experience in hosting and/or supporting regulatory inspections, preferred.

• Preferred working knowledge and understanding of U.S. and International medical device regulations and supporting Quality Systems (audits, management review, quality planning, etc.).

• Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.

• Drive for Results (Service, Quality, and Continuous Improvement) – Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.

• Communication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.

• Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.

• Customer Service Focus – Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations.

Physical Demands

• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes, and bio-hazardous material in the lab environment.

• Ability to sit for extended periods of time.

• Employee may be required to lift routine office supplies and use standard office equipment.

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

• This position requires periodic travel and some evenings, weekends and/or holidays.

• Job may require after-hours response to emergency issues.

• Periodically scheduled on-call may require after-hours response for technical emergencies not explicitly related to assigned job responsibilities.

Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.