Product Quality Engineer 2

Hologic, Inc.; Marlborough (MA); On-site; USD 78,000 - 122,000; Full time

Job summary

Hologic, Inc. is seeking a Product Quality Engineer 2 to provide quality engineering support for on-market medical devices.

You will lead complaint investigations, perform risk assessments, conduct root cause analyses, and drive cross-functional corrective actions to ensure product quality, regulatory compliance, and continuous improvement. This role requires 2–5 years of relevant engineering experience in FDA-regulated environments.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or Biomechanical preferred).
• 2–5 years of relevant engineering experience in FDA-regulated environments.
• Experience with post-market activities: complaint investigations, CAPA evaluation, and regulated product changes.
• Strong communication of findings, recommendations, and scope to stakeholders and leadership.

Responsibilities

• Lead complaint evaluations and investigations for on-market medical devices.
• Perform risk assessments and root cause analysis to drive corrective actions.
• Coordinate cross-functional teams to implement improvements and support CAPA decisions.
• Communicate investigation outcomes and recommended changes to leadership and stakeholders.
• Support change control activities and health risk assessments as needed.

Skills

Complaint investigations

Root cause analysis

Risk assessments

CAPA evaluation

Cross-functional leadership

Change control

Education

Bachelor’s degree in Engineering

Job description

The Product Quality Engineer 2 provides quality engineering support for on-market medical devices by leading complaint investigations, risk assessments, root cause analysis, and cross-functional corrective actions to ensure product quality, regulatory compliance, and continuous improvement.

Knowledge

• Medical device quality systems and regulatory requirements, including FDA Quality System Regulations, Design Controls, ISO 13485, EU MDR, and risk management standards.
• Post-market quality processes, including complaint handling, investigations, risk assessment, Health Risk Assessments, CAPA evaluation, and change control.
• Product design and process change requirements, including documentation updates, testing, verification and validation, and impact assessments.
• Preferred knowledge of test method validation, root cause failure analysis, statistical methods, design of experiments, reliability, electrical safety, sterilization, packaging, biocompatibility, and requirements analysis.

Skills

• Conducts complaint evaluations, investigations, root cause analysis, risk assessments, and trend analysis for on-market medical devices.
• Leads cross-functional teams to determine corrective actions, implement improvements, and support CAPA decisions.
• Communicates investigation findings, root cause, recommended changes, and implementation scope clearly to stakeholders and leadership.
• Assesses product and project documentation for compliance and supports change control activities.
• Presents product quality metrics, investigation outcomes, and recommended resolutions to leadership.
• Coordinates Health Risk Assessment activities and supports Quality Investigation Review boards.
• Performs field investigations at customer sites in partnership with sales, service, and field-based teams.

Behavior

• Works collaboratively across functions and takes ownership of investigations and quality issues.
• Demonstrates sound judgment in prioritizing complaints based on risk, trends, data, and business impact.
• Operates with intermediate autonomy, requiring limited oversight on complex issues.
• Shows strong accountability, compliance mindset, and attention to detail.
• Communicates effectively with technical teams, leadership, and field-based partners.
• Applies company policies and procedures consistently to resolve quality and product issues.
• Takes initiative to lead critical tasks and drive timely resolution.

Experience

• Bachelor’s degree in Engineering required; Mechanical, Electrical, Biomedical, or Biomechanical Engineering preferred.
• 2–5 years of relevant engineering experience.Experience in an FDA-regulated industry preferred.
• Experience in root cause analysis, product development, R&D, or medical device quality engineering is beneficial.
• Experience supporting post-market medical devices, complaint investigations, CAPA evaluation, and regulated product changes is preferred.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $78,000 - $122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.