Quality Assurance Engineer

at Hologic in Newark, Delaware, United States

Job Description

Quality Assurance Engineer

Newark, DE, United States

Our Breast & Skeletal Health division is looking for an experienced Quality Assurance Engineer at our expanding Innovation Center in Newark, Delaware. As part of your responsibilities you will support audit workstreams and/or FDA inspections as applicable.

As a leading innovator of women’s health, we at Hologic are empowering people to live healthier lives everywhere, every day. Apply today and join an organization that makes a true difference!

What To Expect:

To perform functions associated with quality systems and quality assurance operations, including working with all levels and functions within; engineering, supply chain, regulatory, marketing, and all other business functions to investigate process, product, or quality system issues. You will also support in the development and sustainability of methods and procedures for quality assurance and systems.

What We Expect:

+ Collaborate and communicate effectively with junior level employees, peers, and cross-functional teams across all levels of the organization.

+ Responsible for the coordination of assigned Quality efforts and provides support for the Quality Assurance department as directed by the Quality Assurance Manager.

+ Facilitates the following quality assurance functions: Corrective & Preventative Action program, process nonconformance, and administration Divisional Management Review.

+ Provides guidance and expertise on root cause evaluation and monitors CAPA effectiveness post closure.

+ Performs daily reviews of the CAPA system to determine escalations and coordinates with departments to ensure adequate resourcing.

+ Owns and improves divisional CAPA toolbox which includes training and reference materials.

+ Works on documentation and activities stemming from the site CAPA Review Board meetings.

+ Serves as the divisional point of contact for the CAPA process and provides inputs to global process enhancements and training content.

+ Supports in audit preparation efforts including communicating with applicable functional areas and collecting data to ensure audit efficiency.

+ Administrates the collection of divisional Management Review materials.

+ Ability to modify, maintain, and create procedures and processes as applicable.

+ Assisting in data analysis to develop key performance indicators for various functions.

+ Reviews the site’s open Quality Plans (QPL) and provides recommendations for updates.


+ Preferred Minimum Non-Technical Degree: College Degree

+ Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s Degree


+ Preferred Minimum Non-Technical Degree: 3-5 Years in medical device or IVD industry

+ Preferred Minimum Technical/Advanced Degree: 2-4 Years with Technical Bachelor’s Degree, 1-3 Years with master’s degree

+ Experience with Agile or equivalent Product Lifecycle Management system is beneficial.


+ Excellent computer skills including ability to use word processing, spreadsheet programs and databases applications, e.g. enter data, query information and provide reports.

+ Excellent technical writing skills

+ Ability to present materials to director level leadership.

+ Strong interpersonal skills and ability to interact with all levels of the company.

+ Experience in a certified medical device or pharmaceutical manufacturing environment.

+ Experience with Quality Management Systems, in particular, Management Review, Quality System audits and Corrective and Preventive Actions.

+ Ability to document technical work and lead investigations and improvements in a GMP environment.

+ Working knowledge of FDA and ISO regulations that govern the Medical Device is beneficial.

+ Understanding statistics and statistical analysis 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 $74500 – $116,600 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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Job Posting: JC257788265

Posted On: Apr 03, 2024

Updated On: May 07, 2024

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