Quality Manager

‍What You’ll Do

Your Impact

·       Keep Portal’s QMS running cleanly and audit-ready across CAPA, document control, change control, training, and supplier quality

·       Partner cross-functionally with engineering, software, manufacturing, and clinical teams to translate quality requirements into practical, executable solutions

·       Coach and elevate the broader organization on design controls, risk management, and good documentation practices

Key Responsibilities

·       Own and execute core QMS processes day-to-day, including document control, change control, training, CAPA, nonconformance, internal audits, and management review preparation

·       Lead design control activities for the electromechanical drug delivery device, including DHF maintenance, design reviews, traceability, and verification & validation documentation

·       Drive risk management activities (ISO 14971), including hazard analysis, dFMEA/pFMEA/uFMEA, risk-benefit analysis, and risk file maintenance throughout the product lifecycle

·       Manage complaint handling and post-market surveillance, including intake, investigation, MDR/vigilance evaluation, trending, and reporting

·       Plan and conduct internal audits and supplier audits; manage supplier qualification, quality agreements, and supplier corrective actions in partnership with operations

·       Support FDA inspections, notified body audits, and partner audits, including preparation, hosting, real-time response, and follow-up actions

·       Partner with software and systems engineering on IEC 62304 software lifecycle activities, cybersecurity documentation, and software validation

·       Support human factors and usability engineering activities, ensuring documentation aligns with IEC 62366 and FDA HFE expectations for at-home use

·       Drive continuous improvement of QMS workflows, templates, and electronic systems (eQMS) so that processes remain compliant, lean, and easy to follow

·       Develop and deliver QMS, design controls, and risk management training for the broader Portal team

·       Maintain and report quality metrics and KPIs to support management review and leadership decision-making

What We’re Looking For

Required Qualifications

·       Bachelor’s degree in engineering, physical sciences, or life sciences

·       7+ years of quality experience in medical devices, with at least 2 years in a quality lead or manager role

·       Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971; familiarity with EU MDR

·       Hands-on experience with design controls for electromechanical or software-containing medical devices

·       Experience operating CAPA, complaint handling, document control, and internal audit programs

·       Experience supporting FDA inspections, notified body audits, or external partner/customer audits

·       Strong communication, organizational, and cross-functional collaboration skills, with the ability to operate in a fast-paced, evolving environment

Preferred Qualifications

·       Experience with drug-device combination products and 21 CFR Part 4

·       Experience with reusable medical devices, including reprocessing/cleaning validation

·       Familiarity with IEC 62304 (software lifecycle), IEC 60601-1, IEC 62366 (usability), and ISO 10993 (biocompatibility)

·       Experience implementing or administering an electronic QMS (e.g., Greenlight Guru, MasterControl, Veeva)

·       ASQ CQA, CQE, or CMDA certification, or equivalent

·       Experience working in a venture-backed or growth-stage medical device company

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