Manager, Supplier Quality Details

Manager, Supplier Quality

Cue Health - San Diego, CA

Employment Type : Full-Time

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 Manager, Supplier Quality reporting to the Senior

Quality Management System Manager. The Manager, Supplier Quality will support the Quality Management System (QMS) processes related to Supplier Qualifications and Monitoring and, works directly with Purchasing and Supply Chain Logistics.

Other responsibilities include investigation and follow-up of Nonconformance Reports, SCARs and CAPAs, ensuring conformance to applicable Standards and Regulations.

Responsibilities:

• Support Cue Health’s Quality system processes in compliance with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 803, applicable regulatory requirements and Cue Health’s Quality Policy

• Define process improvements and implement solutions to improve the efficiency of the supplier management program

• Maintain Approved Supplier List (ASL)

• Process supplier requests in the eQMS (electronic Quality Management System)

• Act as a liaison with Manufacturing, Quality Engineers, Product Development, and Supply Chain in assessing and addressing quality issues

• Assess potential new suppliers for technical, quality, and manufacturing capabilities

• Manage Supplier Key Performance Indicators (KPIs) and Quality scorecard. Support KPI activities and drive strategic actions from the data related to program improvement

• Implement and develop mechanisms to monitor and identify supplier non-conformance trends

• Work with critical and key suppliers, outsourced manufacturers in development of Supplier Quality Agreements for critical suppliers and distributors/importers

• Works with QA Compliance team on supplier audits/schedules, supplier quality agreements, and distribution agreements

• Contributes to establishing department and company goals, objectives, and accountabilities

• Participates in Material Review Board (MRB) and Correction Action Review Board (CARB) activities to review and disposition CAPAs, SCARs, NCs

• Coordinates with suppliers and identifies areas for supplier quality improvements

• Maintains and updates supplier audit schedules

• Conducts material supplier assessments, notifies supplier of nonconformances, issues SCARs, and reviews corrective actions and follow up activities

• Collaborate with requestors and purchasing to qualify suppliers

• Recruit, train, develop, and lead staff to accomplish organizational goals, adhere to policies/procedures and establish/maintain a ‘culture of quality’

• Manage SCAR process, hold regular status meetings to ensure timely closures by suppliers

• Gather trend data for metrics (SCARs, NCs, supplier performance) on a monthly and quarterly basis

• Provides routine department status updates to management

• Subject Matter Expert during internal and external audits (third party audit) related to Supplier Quality and Purchasing Controls (examples: FDA, Notified Body)

• Assist QA management with special projects

• Other duties as needed

Requirements:

• BS degree in related discipline in engineering, technical, or science field, preferred

• 5+ years of work experience in medical device and biotech manufacturing with good understanding of current Good Manufacturing Practice

• Certified Supplier Quality Professional (CSQP) or equivalent, preferred

• Knowledge of ISO 13485, ISO 14971, IVDD, IVDR, 21 CFR 803, 820

• 4+ years of direct managerial experience

• supporting supplier qualification and monitoring process.

• 5+ years of experience managing CAPAs, Nonconformance Reports, Quality Incidents, SCARs, Planned Deviations and monitoring and trend reporting

• Strong background utilizing Microsoft Office (Microsoft Word, Excel, PowerPoint, etc.), Google Workspace to perform critical job functions, trending, reporting metrics, etc.

• Be an independent, self-starter with exceptional communication (written and verbal) skills, detail oriented, organized, and able to prioritize and balance department workloads in a fast-paced environment

• Demonstrate evidence of a solid background of technical knowledge and experience combined with the proven ability to successfully direct projects and influence people at all organizational levels

• Must possess great communication (written and verbal) skills

• Must be available to work hours outside the normal workday as needed

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

Your contribution will set the pace and have an impact in the technology, health, and diagnostic industry. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a collaborative team on an innovative device. We offer upgraded computer equipment, unlimited snacks, and a competitive salary.

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.