Quality Assurance Specialist, CAPA Investigator

About Us :

Cue Health (Nasdaq: HLTH) is a mission-driven healthcare technology company that puts consumers in control of their health information and places diagnostic information at the center of care. Cue Health enables people to manage their health through real-time, actionable, and connected health information, offering individuals and their healthcare providers easy access to lab-quality diagnostics anywhere, anytime, in a device that fits in the palm of the hand. Cue Health’s first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without physician supervision. Outside the United States, Cue Health has received the CE mark in the European Union, Interim Order authorization from Health Canada, and regulatory approval from India’s Central Drugs Standard Control Organisation. Cue Health was founded in 2010 and is headquartered in San Diego. For more information, please visit www.cuehealth.com .

Cue Health Inc. is seeking to hire a Quality Assurance Specialist, CAPA Investigator , who will be reporting to the Quality Management System Manager. The QA Specialist, CAPA Investigator will support the Quality Management System (QMS) processes which includes but not limited to investigations of CAPA, SCARs, Non-conformances, Planned Deviations and assist with Complaint investigations related to CAPAs/SCARs and ensuring conformance to applicable Standards and Regulations. Responsible for monitoring and reporting compliance to company policies and procedures and partnering with teams to identify and resolve quality issues using risk management and root cause analysis tools. This role requires strong communication, interpersonal and organizational skills and a solid understanding of the application of FDA, IVDD/IVDR and MDSAP requirements and ISO 13485, as well as ISO 14971 (Risk Management) standards.

Responsibilities:

• Support Cue Health’s Quality system processes in compliance with ISO 13485, 21CFR820, ISO 14971, applicable regulatory requirements and Cue Health’s Quality Policy

• Monitor the effectiveness of the CAPA system

• Coordinate all needed training for users of the CAPA eQMS

• Will assist Sr. QA Specialist – CAPA Investigator in CAPA and MRB meetings

• Train area owners on root cause investigations using various tools/methods, assist with defining immediate containment/corrections, define corrective and/or preventive actions with defined due dates for implementation, define verification of effectiveness plan

• Will conduct root cause investigations with area owners in order to ensure timely processing and closure of CAPAs, NCs

• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

• Manage Nonconformance reports (process-related), CAPAs and SCAR processes, hold regular status meetings with area owners to ensure timely closures

• May assist in process metrics and trend monitoring (CAPAs, SCARs, NCs, Planned Deviations)

• Carries out quality system due diligence and integration activities as required by the business

• Assist QA management with special projects

• Other duties as needed

Requirements:

• Applied experience in meeting and applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971)

• BS or equivalent in an engineering, life science or quality discipline; advanced degree is a plus

• A minimum of 3 years of applied experience in the quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic development and/or manufacturing preferred

• Quality Certification preferred (e.g., CQE, CQA, 6-Sigma, or similar certifications

• Experience in a regulated environment

• Broad based technical knowledge and skills in business areas such as Quality Assurance, Quality Systems, Quality Engineering

• Effective data mining, trend analysis, statistical analysis

• Intermediate to advanced experience with word processing and spreadsheets

• Intermediate to advanced experience with charting and graphing tool

• Strong communication, facilitation, planning, problem-solving and organizational skills

• Strong influencing and negotiation skills

• Demonstrate effective project management skills and collaboration on teams in multiple locations is desired

• Good judgment and decision-making skills; knows how to make trade-off decisions while balancing compliance and business impact

• Experience with quality and process improvement methodologies and tools

• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands

• Ability to execute strategy, approach, methods and actions on new assignments

• Operates with high level of independence to investigate and resolve compliance issues, plan and implement improvements, and achieve goals

Environment and Physical Activities/Requirements :

• You will work in an indoor office environment for which no adverse conditions are expected. This position requires the following physical activities and/or requirements:

  • Remaining in a stationary or sedentary position, often standing and/or sitting for prolonged periods of time

  • Repeating motions, such as keyboarding, that may include the wrists, hands, and/or fingers

  • Communicating with others to exchange information

  • Adjusting, moving, carrying, lifting, pushing or pulling objects up to 20 pounds

Cue Health Inc. is an equal opportunity employer, consistent with applicable laws. Individuals seeking employment are considered without regards to race, color, religion (including religious accommodations), creed, sex (including pregnancy, childbirth and related medical conditions), gender (including gender identity and expression), sexual orientation, marital status, national origin (including language use restrictions), ancestry, mental and/or physical disability, medical condition (cancer, genetic information and characteristics, requests for medical and family care leave), age, military or veteran status, and any other classification protected by applicable federal, state, and local laws.