Manufacturing Data Coordinator

Hologic•Marlborough, MA

7d•$46,400 - $69,600

About The Position

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

Requirements

High school diploma or equivalent technical school education preferred.
Minimum of 3–5 years of related quality inspection experience in a medical manufacturing environment.
Experience with Oracle and Agile preferred.
Strong attention to detail and accuracy in documentation review and inspection processes.
Ability to work independently with minimal supervision and make informed decisions.
Excellent interpersonal and communication skills.
Thorough understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Familiarity with quality management systems (QMS) and regulatory requirements in the medical device industry.
Ability to interpret engineering drawings, specifications, and technical documents.
Proficiency with quality tools, metrics, and software systems (e.g., Oracle, Agile preferred).
Strong organizational skills to maintain accurate records, logs, and reports.
Commitment to continuous improvement and operational excellence.

Nice To Haves

Experience with Oracle and Agile preferred.
Proficiency with quality tools, metrics, and software systems (e.g., Oracle, Agile preferred).

Responsibilities

Perform detailed reviews of Device History Records (DHRs) for finished products, ensuring accuracy and compliance with documentation standards prior to final release.
Communicate and reinforce Good Manufacturing Practices (GMP) to manufacturing personnel to uphold quality standards.
Generate folders and labels for manufacturing product lines as needed.
Support production lines by assisting the process leader with material receipt and process control.
Enter all material movement transactions into the ERP system, including receipt, transfers, consumption, outputs, sales, and labeling; ensure proper management, custody, and confidentiality of records and documents.
Backflush work orders, manage cycle count activities, and support time study validation.
Participate in Kaizen events and conduct 5S implementation and audits to maintain standards.
Perform other duties as assigned to meet organizational and operational needs.
Ensure compliance with all company policies and procedures, including safety regulations, Personal Protective Equipment (PPE) requirements, Standard Operating Procedures (SOPs), Quality Management System regulations (QMSR), ISO standards, and Good Documentation Practices (GDP).
Demonstrate a strong commitment to company core values: integrity, respect, collaboration, and innovation.
Contribute to a positive and inclusive work environment by supporting colleagues and promoting teamwork.
Engage in continuous improvement initiatives to drive operational excellence and efficiency.