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Quality Assurance Coordinator 4

Newark, DE, United States

Are you passionate about quality and regulatory compliance? At Hologic, we are seeking a **Quality Coordinator 4** to play a vital role in supporting quality inspection and manufacturing quality functions. In this role, you’ll ensure compliance with regulatory requirements, maintain documentation standards, and drive continuous improvement initiatives. You’ll perform quality control inspections, manage critical documentation, coordinate training, and act as a liaison between manufacturing, quality assurance, and engineering teams. If you’re detail-oriented, organized, and driven by a commitment to excellence, this is your opportunity to make a meaningful impact on the quality of life-saving products.

Knowledge:

+ Deep understanding of FDA 21 CFR Part 820 and ISO 13485 Quality Management System (QMS) requirements.

+ Working knowledge of Good Documentation Practices (GDPs) and Good Manufacturing Practices (GMPs).

+ Familiarity with Quality Management Systems such as Agile and Oracle.

+ Knowledge of quality inspection processes and documentation control in a regulated industry.

+ Awareness of regulatory documentation requirements, including environmental monitoring and pest control reporting.

Skills:

+ Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

+ Strong attention to detail to ensure accuracy in inspections, documentation, and compliance.

+ Excellent interpersonal and communication skills to liaise effectively with cross-functional teams.

+ Organizational skills to manage multiple tasks and prioritize in a fast-paced environment.

+ Problem-solving and analytical skills, with a focus on continuous improvement and error reduction.

+ Capable of developing and facilitating onboarding and ongoing manufacturing quality training.

+ Strong ability to review, maintain, and support quality metrics and documentation.

Behaviors:

+ Collaborative and team-oriented, fostering alignment between manufacturing, quality assurance, and engineering teams.

+ Proactive and adaptable, with the ability to identify and address quality issues efficiently.

+ Committed to compliance and maintaining high standards of quality in all tasks.

+ Continuous improvement mindset, driving process enhancements and reducing errors.

+ Reliable and dependable, ensuring timely completion of tasks and adherence to regulatory requirements.

+ Takes ownership of quality plans and metrics, ensuring data accuracy and completeness.

Experience:

+ 3+ years of experience working in a regulated industry, such as medical devices, pharmaceuticals, or biotech.

+ Proven experience in quality inspection, documentation control, or manufacturing quality systems.

+ Hands-on experience with regulatory documentation and quality audits.

+ Familiarity with cleanroom environments, kaizen events, and manufacturing quality processes.

Education:

+ High school diploma or GED required; Associate’s degree in Quality Assurance, Engineering Technology, Life Sciences, or a related technical field 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 $67,900-$101,800 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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Same Posting Description for Internal and External Candidates