Quality Assurance Engineer 2

Newark, DE, United States

Join Hologic Inc., a leader in the medical device industry, where innovation and quality are our top priorities. We are committed to delivering high-quality products that meet regulatory standards and improve patient outcomes.

As a Quality Assurance Specialist , you will collaborate with various functions within the organization to investigate and resolve process, product, or quality system issues. You will use sophisticated programs to collect and evaluate data, support audit workstreams, and ensure compliance with quality assurance standards.

Key Responsibilities:

• Quality Leadership:

• Model and support BSH quality system requirements and standards.

• Elevate team capabilities in producing high-quality products and implementing best practices.

• Collaboration and Communication:

• Work effectively with junior employees, peers, and cross-functional teams.

• Coordinate assigned quality efforts and support the Quality Assurance department.

• Quality Assurance Functions:

• Facilitate Corrective & Preventative Action (CAPA) programs and process nonconformance.

• Provide guidance on root cause evaluation and monitor CAPA effectiveness.

• Review and manage CAPA system escalations and resource coordination.

• Own and improve the divisional CAPA toolbox, including training and reference materials.

• Serve as the divisional point of contact for the CAPA process.

• Audit Participation:

• Support internal and external quality audits, including audit preparation and data collection.

• Administrate divisional Management Review materials.

Qualifications:

• Education:

• Preferred: Technical Bachelor’s Degree in a related field.

• Minimum: College Degree with 3-5 years of experience in the medical device or IVD industry.

• Experience:

• 2-4 years with a Technical Bachelor’s Degree, 1-3 years with a Master’s Degree.

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

• Skills:

• Excellent computer skills, including word processing, spreadsheet programs, and databases.

• Strong technical writing and detail-oriented skills.

• Ability to present materials to director-level leadership.

• Strong interpersonal skills for effective interaction at all company levels.

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

• Working knowledge of FDA and ISO regulations is beneficial.

• Understanding of 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 $76,800 - $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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