Post Market Quality Engineer

Hologic • Newark, DE

101d • $72,100 - $112,800

About The Position

As a Post Market Quality Engineer, you will provide quality engineering support for on-market medical devices. This role is responsible for evaluating post-market feedback, investigating complaints, performing risk assessments and root cause analyses, and leading cross-functional teams to implement improvements based on investigation findings. This role sits in Newark, DE and will require onsite presence Monday through Thursday with a remote day on Friday.

Requirements

• Bachelor's degree in Engineering required (Mechanical, Electrical, Biomedical, or Biomechanical preferred).
• 2-5 years of experience in engineering, ideally within an FDA-regulated industry.
• Experience in root cause analysis or product development/R&D is a plus.
• Solid working knowledge of FDA Quality System Regulations (especially Design Control), ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management, GMP, and GDP.
• Ability to work effectively on project teams, including leading critical tasks to ensure timely and appropriate resolution.
• Skilled at reviewing and assessing product/project documentation for compliance, with strong communication of findings and recommendations.
• Proficient with root cause analysis tools and techniques; able to lead investigations for complaints, non-conformances (NCs), and CAPAs.
• Strong communication and presentation skills.
• Demonstrates intermediate autonomy and independence, requiring minimal oversight when solving complex problems.

Responsibilities

• Prioritize complaints and investigations using product risk, data analysis, trending, and strategic impact.
• Own complaint investigations and associated root cause analyses, coordinating collaboration and communication with stakeholders.
• Partner with cross-functional teams to communicate findings, determine if CAPA is required, and scope recommended changes.
• Perform Health Risk Assessments and coordinate with internal teams to ensure efficient and effective evaluation of on-market products.
• Lead cross-functional teams in implementing improvements or corrections resulting from complaint investigations.
• Perform data analysis and trending of complaints and failure modes, identify mitigations for threshold risks, and prepare/present findings to internal stakeholders.
• Lead projects to implement design or process changes, including updating drawings, fixtures, tooling, testing, and change control documentation.
• Develop and improve testing methods used during complaint investigations and root cause activities.
• Train and support the complaint intake team by providing technical expertise for complex investigations.
• Assess product changes for impact on design and risk management, and determine supporting information required for implementation.
• Provide post-market feedback to Operations, Engineering, and R&D, leveraging complaint trends and other forums to drive continuous product improvement.
• Apply company policies and procedures to resolve a variety of issues, developing professional expertise and judgement.
• Perform on-site investigations at customer locations, collaborating with field-based teams (sales, service) to urgently resolve field quality issues while upholding the Hologic brand.
• Present product quality metrics to Leadership, explain root causes, and recommend actions/resolutions.
• Participate actively in internal and external audits, including facility, supplier, Notified Body, and FDA inspections.
• Support monthly Quality Investigation Review boards by preparing and presenting relevant materials.
• Travel to customer sites - 25% travel.

Benefits

• Comprehensive training when you join as well as continued development and training throughout your career.
• Competitive salary and annual bonus scheme.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree