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Product Quality Engineer

Product Quality Engineer

Precision Monitoring LLCSanta Clara, CA, US
1 day ago
Job type
  • Full-time
Job description

Job Description

Job Description

Position : Product Quality Engineer (PQE) – Medical Device Manufacturing

Shift : 8 : 00am to 5 : 00pm

Location : Ft Worth, TX or San Diego, CA (remote / hybrid)

Travel : 25% - 50% (including some international travel)

Reports to : Sr. Director of Quality and Regulatory

Company Overview

Precision Monitoring is a leading innovator in healthcare diagnostics, offering remote monitoring and enterprise management solutions that drive better outcomes across the healthcare continuum. We specialize in Holter, Event, and Telemetry monitoring systems that simplify complex workflows for providers operating in a highly regulated environment.

Our culture promotes analytical thinking, innovation, and a commitment to excellence. As we continue to expand, we’re seeking passionate professionals who bring energy, integrity, and a results-driven mindset to join our growing team. We offer competitive compensation, comprehensive medical benefits, and a collaborative work environment.

Position Summary

We are seeking a Product Quality Engineer (PQE) to lead product quality assurance, manufacturing readiness, and supplier management and coordination efforts for its FDA-regulated cardiac monitoring systems. This role serves as a critical bridge between engineering, quality, and manufacturing, ensuring that all products meet regulatory, performance, and reliability standards. The PQE will also dedicate approximately 25% of their time managing supply chain and contract manufacturing partners to maintain quality alignment and operational continuity.

Key Responsibilities :

  • Product Quality & Compliance (Core ~75%)
  • Supply Chain & Contract Manufacturing (~25%)

Essential Functions :

Product Quality & Compliance (Core ~75%)

  • Lead product quality engineering activities for remote cardiac monitoring devices (Pods, Gateways, Patches, Chargers, Batteries).
  • Manage nonconformances (NCR), corrective and preventive actions (CAPA), supplier deviation reports, and failure analyses.
  • Support design and development activities related to UDI labeling requirements and ensure accurate and timely submission of UDI data to the FDA database (GUDID).
  • Support and improve quality system documentation ensuring continued compliance to FDA 21 CFR 820 and ISO 13485 : 2016 requirements.
  • Conduct First Article Inspections (FAI) and Design / Process Validation (IQ / OQ / PQ) for new and transferred products. Ensure the products Master Validation file is maintained.
  • Partner with R&D to ensure design inputs, risk management (ISO 14971), and verification / validation protocols align with quality standards.
  • Review Device History Records (DHRs), Device Master Records (DMRs), and inspection plans for completeness and compliance.
  • Analyze product returns (RMAs), field failures (Complaints), and yield metrics to identify trend, open CAPAs related to trends identified and drive root cause corrective actions.
  • Supply Chain & Contract Manufacturing (~25%)

  • Coordinate with key manufacturing partners (ClearPath, Sigmatronix, Plastikon, Social Mobile, PHD Battery, SGA) on product quality, supplier performance, and audit readiness.
  • Provide oversight of supplier CAPAs and audit response closure.
  • Implement improvements and oversee incoming inspection criteria, supplier scorecards, and supplier quality agreements.
  • Collaborate with Operations to manage build readiness and ensure consistent delivery schedules.
  • Continuous Improvement

  • Identify and lead process improvement initiatives to reduce defects and optimize yields.
  • Drive supplier and internal quality metrics (FPY, DPPM, OTD, RMA) tracking and reporting. Including performing trend analysis for Management Review reporting.
  • Contribute to Lean / Six Sigma and risk-based quality programs supporting scalability.
  • Qualifications

    Required Qualifications

  • 5–8 years of experience in medical device quality engineering, ideally in Class II or III devices.
  • Demonstrated expertise in quality systems, supplier quality, product development, and manufacturing liaison roles.
  • Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 (Risk Management).
  • Proficient in CAPA, NCMR / NCR, UDI-DI, validation protocols, and documentation control systems.
  • Familiarity with ERP / MRP tools (e.g., NetSuite, Arena, or equivalent).
  • Strong communication, analytical, project coordination, and problem-solving skills.
  • Bachelor’s degree in engineering (Biomedical, Mechanical, Electrical, or related).
  • Ability to travel 25% to 50%
  • Ability to travel International as needed
  • Preferred Qualifications

  • Experience in electronic and mechanical subassembly manufacturing.
  • Familiarity with DFM / DFX principles and supplier transfer validation.
  • Six Sigma Green Belt or equivalent certification.
  • Hands-on experience supporting global suppliers or CMOs.
  • Comfortable working with KPIs and performance-based metrics.
  • Ability to accept and apply constructive feedback with professionalism.
  • Demonstrated accountability and ownership of outcomes.
  • Success in This Role Means

  • Sustained product compliance and supplier performance across all contract manufacturers.
  • Reduction in field failures and nonconformances through proactive quality engineering.
  • Consistent readiness for FDA and ISO audits.
  • Effective coordination between Quality, Engineering, Manufacturing, and Supply Chain teams.
  • Demonstrated ownership of product reliability and supplier quality outcomes.
  • Opportunity Statement

    Precision Monitoring is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace and do not discriminate based on race, color, religion, gender, national origin, age, disability, genetics, veteran status, sexual orientation, or any other protected characteristic under applicable law. This policy applies to all employment practices including hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

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