Join Our Team as a Quality Engineer and Drive Excellence in Post-Market Analysis!

Are you passionate about ensuring product quality and eager to make a significant impact in the medical device industry? We are seeking two dedicated Quality Engineers to join our team in Newark, DE and lead critical evaluations, investigations, and root cause analyses based on post-market feedback and field complaints.

If you are ready to take on a challenging and rewarding role that allows you to drive product quality and innovation, apply today and become an integral part of our mission to enhance women's health and well-being!

 

 

What to Expect:

In this role, you will be responsible for processing and evaluating product returns for our manufactured and distributed products, ensuring compliance with applicable regulations, standards, and internal procedures. You will design innovative methods and procedures for inspecting, testing, and evaluating the functionality and quality of product returns.

Your ability to prioritize investigations based on product risk, data analysis, trending, and strategic impact will be crucial in driving our quality initiatives forward. You will also collaborate with cross-functional teams to implement improvements or corrections based on the findings from complaint investigations.

You will collaborate with exceptional teams to drive the implementation of improvements and corrective actions based on your investigation results. Your insights will be pivotal in fostering a culture of continuous improvement and innovation.

What We Expect:

Lead moderate to complex risk management, defect investigation, product investigation and corrective action activities. 
  Monitor and provide regular communication and updates on success factors such as progress, schedule, budget, project risks and resource of needs gaps. 
  Responsible for assigned department metrics and leads projects or initiatives to reach departmental goals. 
  Responsible for improving product reliability and reducing complaint volumes. 
  Collaborates with Service, Operations, Marketing, Engineering, Quality and R&D.  Accountable for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations. Responsible for product and manufacturing process expertise.
  Perform a variety of activities related to analysis of product quality issues, including attending customer sites to aid investigations.
  Own “INV” investigations and present data to cross functional teams to determine if further action such as a CAPA is required.
  Investigate OBFs and products returns related to customer complaints; providing timely and insightful response to investigations, including direct responses to customers regarding status of product and investigation results.
  Conduct timely analysis of data, development of investigation plans and execution of investigations to identify root cause(s). Identify appropriate risks associated with complaint events and investigation results. Perform associated risk calculations to make risk assessment decisions Utilizes root cause analysis tools for applicable investigations.
  Manages and performs monthly Quality Investigation Review boards including, leading, assembling, and presenting to key stake holders.
  Provide visibility to the status of INVs, CAPAs, and SCARs and track to completion.

 

Qualifications and Skills

Education

Bachelor’s in Engineering (mechanical / biomedical/ Biomechanical / Electrical)

 

Experience    

 5+ Years with experience in related environment 
  FDA regulated industry is beneficial. 
   Experience with cleanroom processes is beneficial. 

 

Skills
       
 

Excellent computer skills including ability to use word processing, spreadsheet programs and databases.
       
   Excellent technical writing skills with ability to write quality assurance reports and details procedures.      
   Strong analytical skills including trend and statistical analysis, interpersonal, and management skills.       
   Ability to plan and supervise execution of projects, keep to timelines, and prioritize resources.
   Ability to troubleshoot and solve technical issues across multiple assays and platforms.
   Ability to analyze data and come to valid scientific conclusions.
   Ability to document technical work and lead investigations and improvements in a GMP environment.
   Knowledge of manufacturing, investigation, and quality improvement methodologies such as GMP, GDP CIMS, Lean, Root Cause and Root Cause Failure Analysis, TQM, SPC and Six Sigma.
   Excellent collaboration and interpersonal skills.   Working knowledge of FDA and ISO regulations that govern the Medical Device is beneficial.
        Certified Quality Engineer is beneficial.
       
 
So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. 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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!
 
The annualized base salary range for this role is $83,000 - $129,700  and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.