Quality Engineer 2

Why Hologic?

Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.

Our innovations are designed to achieve exceptional clinical results, making it possible to detect, diagnose and treat illnesses and other health conditions earlier and more effective.

Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses. 

What to expect:

• Performs evaluations, investigations, and root cause analyses in relation to post market feedback and complaints from the field. 
• Responsible for processing and evaluating product returns for manufactured and distributed products as required by applicable regulations, standards, and internal procedures. 
• Processes and owns complaints as a facilitator from initiation to closure to ensure validity of the complaint and adequate information and codes are assigned to the records. 
• Provide input in prioritization of complaints and investigations based on product risk, data analysis and trending, and strategic impact. 
• Lead cross functional team in implementation of improvements or corrections based on the results of complaint investigations. 
• Work on complex electromechanical device with software and hardware.
• Works with intermediate level of autonomy and independence, requiring minor oversight on complex problems with analysis requiring a variety of factors.  
• Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships. 
• Performs investigations in the field at customer sites partnering with field-based teams, including sales and service. 
• As applicable, lead project to implement design or process change including drawing update, fixture and tooling update, performing testing and change control documentation. 
• Partner with cross functional team and communicate root cause, recommended changes and scope effort to implement changes as needed. 
• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.  Normally receives general instructions on routine work, detailed instructions on new projects or assignments. 

What we expect:

• Own Investigations and work with cross functional teams to determin if CAPA is required.
• Conduct timely analysis of data, development/execution investigative plan.
• Partners with Field Service and Technical Support for required documentation.
• Work closely with R&D, Manufacturing Operations, Service, and Supplier Quality.
• Customer site visits as needed.
• Present product qualit ymetrics to Leadership, explain root cuase, and recommend actions/resolutions.
• Supports monthly Quality Investigation Review boards.

Education & Experience:

• Bachelor's degree required in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering with 3 years experience
  • Experience in an FDA regulated industry is beneficial. 
  • Experience in root cause analysis or product development/R&D is beneficial. 

The annualized base salary range for this role is $78,00 to $118,400 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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