Post Market Quality Engineer 2

Newark, DE, United States

Here at Hologic it is our purpose to enable healthier lives everywhere, every day. We are driven by our passion to become the global champion for women’s health. We achieve this by fulfilling our promise to bring The Science of Sure to life. We are looking for a skilled and experienced Post Market Quality Engineer to join our Breast and Skeletal Health Division in our expanding Innovation Center in Newark, DE.

This indivudual will conduct evaluations, investigations, and root cause analyses for post-market feedback and complaints.

What To Expect:

• Process and assess product returns in compliance with regulations, standards, and internal procedures.

• Develop methods for inspecting, testing, and evaluating product returns.

• Prioritize investigations based on product risk, data analysis, and strategic impact.

• Collaborate with cross-functional teams to implement improvements and corrective actions.

• Support moderate to complex risk management, defect investigation, and corrective action activities.

• Monitor and communicate progress, schedules, budgets, project risks, and resource needs.

• Lead projects to achieve departmental goals and improve product reliability.

• Ensure products meet regulatory and quality standards.

• Analyze product quality issues, including on-site customer investigations.

• Conduct root cause analysis and risk assessments.

• Support Quality Investigation Review boards and track the status of investigations and corrective actions.

• Maintain investigation lab and documentation.

• Assist in regulatory inspections related to product quality investigations.

• Present investigation trends and improvement recommendations to management.

• Perform data queries and trend analysis on product problems/complaints.

• Manage quality data reporting for post-market surveillance and Management Review.

What We Expect:

• Onsite in Newark, DE.

• Bachelor’s Degree in a technical field preferred; Master’s Degree is beneficial.

• 2-5 years of industry experience

• Excellent computer, technical writing, problem-solving, root cause analysis, and analytical skills.

• Strong project management and collaboration abilities.

• Experience in GMP, GDP, Lean, Root Cause Analysis, TQM, SPC, and Six Sigma.

• Knowledge of medical device regulations (21CFR820), ISO 13485, and MDD is beneficial.

• Certified Quality Engineer and experience with cleanroom processes are advantageous.

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 $76,800 to $120,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

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

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