Senior Medical Device Quality Leader — Data-Driven

Jobtailor; Danvers (MA); On-site; USD 130,000 - 190,000; Full time

Job summary

Jobtailor is seeking a Product Quality Engineering lead to guide quality strategy across assigned product families throughout the lifecycle. You will drive investigations, CAPA, and data-driven improvements in collaboration with manufacturing and sustaining engineering teams.

Responsibilities include monitoring quality metrics, leading cross-functional reviews, and developing dashboards and KPI reporting to protect product reliability and customer satisfaction.

Qualifications

• B.S. in Engineering required.
• Mechanical, Electrical or Mechatronics Engineering degree preferred.
• 10+ years of experience in manufacturing or service of electro-mechanical or other complex systems.
• Proven problem solver & clear thinker.
• Skilled in leading quality investigations and quality improvement projects to deliver exceptional results within a predictable timeline.
• Communicate clearly (written and oral) with other company personnel, vendors, regulatory agencies, auditors and customers.
• Flexible: able to follow directives and accomplish tasks outside of normal duties.
• Proficiency with MS Office Suite (Excel, Word, PowerPoint, Outlook, etc.) and Minitab.
• Knowledge of Medical Device Regulatory & Quality Standards: ISO 13485 / MDSAP / EU MDR IEC 60601-1 / ISO 14971.
• Strong technical understanding of imaging system performance testing and regulatory compliance.

Responsibilities

• Serve as the Product Quality Engineering lead for assigned product families throughout the product lifecycle.
• Monitor and analyze quality performance metrics, manufacturing yield data, complaint trends, service data, and field reliability indicators.
• Establish and maintain product quality dashboards and KPI reporting.
• Drive continuous improvement initiatives to improve product quality, reliability, manufacturability, and customer satisfaction.
• Act as the primary quality representative for cross-functional product teams.
• Lead investigations of product failures, nonconformances, customer complaints, and field-returned devices.
• Perform data-driven root cause analyses using quality tools including: 5 Whys, Pareto Analysis, Fishbone Analysis, Statistical Analysis, FMEA, and others.

Skills

Root Cause Analysis

Statistical Analysis

FMEA

5 Whys

Pareto Analysis

Fishbone Analysis

Quality Performance Metrics

Manufacturing Process Improvement

Product Quality Dashboards

KPI Reporting

Problem Solving

Clear Communication

Flexibility

Education

B.S. in Engineering

Tools

MS Office Suite

Minitab

Job description

Jobtailor is seeking a Product Quality Engineering lead to guide quality strategy across assigned product families throughout the lifecycle. You will drive investigations, CAPA, and data-driven improvements in collaboration with manufacturing and sustaining engineering teams.

Responsibilities include monitoring quality metrics, leading cross-functional reviews, and developing dashboards and KPI reporting to protect product reliability and customer satisfaction.