Product Quality Engineer – Post Market Surveillance

QvalFocus Inc. is seeking a Product Quality Engineer to provide quality engineering support for on-market medical devices. This role focuses on complaint investigations, root cause analysis, and post-market quality activities to ensure product quality and regulatory compliance.

Responsibilities:

• Lead complaint investigations, root cause analysis, and risk assessments for post-market medical device issues
• Prioritize complaint investigations based on product risk, trending data, and business impact
• Coordinate cross-functional collaboration with Quality, Engineering, Operations, R&D, Manufacturing, and Regulatory teams
• Conduct Health Risk Assessments (HRA) and evaluate field issues to determine product impact and required actions
• Identify and implement corrective actions, CAPAs, and product or process improvements based on investigation findings
• Perform complaint trending, failure analysis, and data analysis to identify recurring issues and risk thresholds
• Present investigation findings, quality metrics, root causes, and recommendations to leadership and stakeholders
• Lead implementation of design or process changes including change control documentation, testing activities, fixture/tooling updates, and drawing revisions as applicable
• Develop and improve testing methods used for complaint investigations and failure analysis activities
• Assess product changes for design, quality, and risk management impact
• Provide post-market quality feedback to Engineering, Operations, Manufacturing, and R&D teams to improve product performance and reliability
• Support complaint intake teams with technical guidance and complex investigations
• Participate in field investigations and customer site evaluations alongside service and field-based teams when required
• Support internal and external audits, supplier audits, FDA inspections, and Notified Body audits
• Support Quality Investigation Review Boards and prepare investigation summaries, reports, and presentations

Requirements:

• Bachelor's degree in Mechanical, Biomedical, Biomechanical, Electrical Engineering, or related engineering discipline
• 5+ years of experience with a Bachelor's degree OR 1–3 years with a Master's degree OR 0–1 years with a PhD
• Experience within FDA-regulated industries, preferably medical devices
• Strong experience with complaint investigations, root cause analysis, CAPA, and post-market quality activities
• Working knowledge of FDA Quality System Regulations, Design Controls, ISO 13485, EU MDR, GMP, GDP, and risk management principles
• Strong understanding of root cause analysis methodologies and quality investigation tools
• Excellent communication, technical writing, presentation, and cross-functional collaboration skills
• Ability to work independently with minimal oversight in fast-paced, regulated environments
• Experience in product development, R&D, or design engineering
• Familiarity with test method validation, statistical analysis, DOE, and reliability testing
• Experience with verification & validation (V&V) activities for regulated products
• Familiarity with sterilization, packaging, electrical safety, biocompatibility, and reliability standards
• Experience with risk-based analysis and statistical evaluation methods
• Knowledge of requirements analysis and development of measurable product specifications
• Strong analytical and problem-solving skills
• Ability to manage multiple investigations and priorities simultaneously
• Detail-oriented with strong documentation and compliance focus
• Proactive mindset with strong ownership and accountability
• Ability to lead critical quality investigations and drive resolution activities effectively