Staff Quality Engineer

PETcoil; Sunnyvale (CA); Presencial; USD 145.000 - 195.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Stock options

Medical, dental, and vision plans

401(k) retirement savings plan

Descripción de la vacante

PETcoil, a clinical-stage health technology startup, seeks a Staff Quality Engineer to build and maintain a scalable QMS and lead quality activities across design controls, risk management, audits, V&V, supplier quality, and manufacturing. You will partner with cross-functional teams to ensure audit-ready quality systems and successful commercialization.

The role requires 8+ years in medical device quality, strong knowledge of FDA QMSR, ISO 13485, and GDP, and excellent communication to

Formación

• Experience implementing a QMS at a medical device startup (<50 employees).
• 8+ years in quality assurance/engineering in medical devices.
• Strong knowledge of FDA 21 CFR Part 820 / QMSR, ISO 13485, ISO 14971, IEC 60601, IEC 62304, GDP.
• Strong communication and cross-functional collaboration skills.

Responsabilidades

• Own the QMS oversight, ensuring audit-ready processes and documentation.
• Lead design controls, risk management, and V&V activities.
• Manage supplier quality, inspections, and release criteria.
• Coordinate internal and external audits and management reviews.
• Provide quality training and guidance to cross-functional teams.

Conocimientos

QMS leadership

Regulatory knowledge

Audits

Risk management

V&V

GDP

Educación

Bachelor's degree in engineering

Descripción del empleo

Company Description

PETcoil is a clinical-stage health technology startup with a vision to make multimodality medical imaging accessible to every patient. We are commercializing a novel portable time-of-flight positron emission tomography (PET) technology that enables PET and combined PET/MRI exams at a fraction of the cost of existing solutions. Our technology is designed to support the characterization of a range of diseases, starting with neurological disorders.

Position Overview

The Staff Quality Engineer is responsible for building and maintaining a scalable, compliant Quality Management System (QMS) and leading quality activities across design controls, risk management, audits, verification and validation (V&V), supplier quality, and manufacturing. You will partner closely with cross-functional teams to ensure the product and quality system is effective, audit-ready, and prepared for commercialization.

Responsibilities

Quality Management System (QMS) Oversight

• Establish and maintain an efficient Quality Management System (QMS) that complies with applicable standards and regulations, including ISO 13485 and the FDA Quality Management System Regulation (QMSR), and is optimized for a growing startup.
• Own Document Control and all QMS processes and documentation, ensuring they remain accurate, current, and audit-ready.
• Lead internal and external audits conducted by regulatory authorities and notified bodies, including preparation, auditor interactions, reporting, and resolution of findings.
• Provide quality training and guidance to Engineering, Product, and other cross-functional teams.
• Coordinate and facilitate management reviews by providing meaningful quality data, trend analyses, and actionable recommendations.

Design Controls and Risk Management

• Own the Design History File (DHF) from concept through commercialization, ensuring completeness, traceability, audit readiness, and effective design transfer.
• Partner with Engineering to define and maintain design inputs, design outputs, and traceability matrices.
• Lead design reviews and assess the quality, regulatory, and risk impact of design changes.
• Develop and maintain the product risk management file, including the identification and analysis of risks associated with product use, design, manufacturing, and suppliers.
• Support the planning and execution of design V&V activities.

Manufacturing and Supplier Quality

• Lead supplier quality activities, including qualification, audits, first article inspections, performance monitoring, and corrective actions.
• Support incoming and in-process inspections and establish final acceptance and release criteria.
• Support the calibration and maintenance of inspection, measurement, and test equipment.

Qualifications

Required

• Experience implementing and maintaining a QMS at a medical device startup with fewer than 50 employees, preferably as a Quality Lead or Quality Manager.
• A minimum of 8 years of experience in quality assurance or quality engineering within the medical device industry.
• Strong working knowledge of medical device quality and regulatory requirements, including FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and Good Documentation Practices (GDP).
• Strong communication skills with the ability to influence, collaborate, and build relationships across internal teams, suppliers, and external stakeholders.
• Experience managing audits and interacting with the FDA, competent authorities, other regulatory agencies, and notified bodies.
• Experience with risk-based V&V and process validation.
• Interest in working in a fast-paced, dynamic startup environment with flexibility to take on responsibilities beyond position’s primary scope.
• Passion for developing reliable medical imaging solutions that improve healthcare.
• Bachelor’s degree in engineering or a related technical field, preferably mechanical, electrical, or mechatronics engineering.

Preferred

• Experience working with complex electromechanical medical devices.
• Relevant certifications, such as ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), Six Sigma Green Belt or Black Belt, or ISO 13485 Lead Auditor.
• Strong technical understanding of imaging system performance testing and applicable regulatory standards.

Compensation and Benefits

• Annual base salary range of $145,000 to $195,000
• Employee stock options
• Medical, dental, and vision plans
• 401(k) retirement savings plan