"Alerted.org

Quality Supply Assurance Specialist II

San Diego, CA, United States

Are you driven by quality, detail, and making sure issues are resolved the right way the first time? Hologic is seeking a **Quality Supply Assurance Specialist II** to support our business operations by ensuring timely resolution of quality issues while maintaining full compliance for non-conformances and associated quality records. In this role, you’ll work cross-functionally to support MRB and product quality forums, guide investigations, and contribute to continuous improvement across our Quality Management System. If you enjoy working in a highly detailed, regulated environment and want to help ensure safe, reliable products reach our customers, this role is for you.

Knowledge

+ Working knowledge of FDA Quality System Regulations and ISO 13485.

+ Familiarity with risk management concepts and quality workflows related to non-conformances, corrections, and corrective actions.

+ Understanding of Quality Systems elements such as Material Review Board (MRB), Product Quality Committee (PQC), and quality metrics.

+ Knowledge of ERP-based quality transactions and basic quality data reporting.

Skills

+ Ability to review and assess non-conformance, correction, and corrective action records for accuracy, completeness, and appropriateness.

+ Strong facilitation skills to support and coordinate cross-functional meetings (MRB, PQC, Product Response Team).

+ Proficiency in Microsoft Word, Excel (including graphing and data presentation), and related office tools.

+ Experience working in ERP systems (strongly preferred).

+ Excellent oral and written communication skills, including clear technical writing for quality records and SOP support.

+ Ability to support investigations using quality workflows, trend queries, and other analytical tools.

+ Strong organizational and multitasking skills in a detail-oriented, regulated environment.

Behaviors

+ Self-starter who works effectively with minimal supervision.

+ Detail-focused and diligent in maintaining compliant, accurate quality records.

+ Collaborative team member who enjoys partnering across departments and acting as a QA interface.

+ Continuous improvement mindset, actively contributing ideas to improve processes and quality system performance.

+ Accountable and reliable, ensuring timeliness in deliverables and follow-through on quality commitments.

Experience

+ BA/BS degree required, or equivalent experience/certification.

+ **2+ years** of experience in Quality, with strong emphasis on Quality Systems and non-conformances.

+ Experience in an FDA-regulated environment is required.

+ Experience supporting external audits and regulatory body inspections is beneficial.

+ ASQ Certification (CQA, CQE) preferred.

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 $65,900- $103,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, 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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