Manufacturing Data Coordinator

DIRECT SALES, US; Marlboro (MA); On-site; USD 46,000 - 70,000; Full time

Job summary

Hologic is seeking a Manufacturing Data Coordinator to review Device History Records, reinforce GMP practices, and manage ERP data entry for material movements. The role supports production, performs backflush, cycle counts, and 5S audits to maintain high standards.

The ideal candidate has 3–5 years of quality inspection experience in medical manufacturing, with familiarity in Oracle and Agile, and strong attention to detail.

Qualifications

• 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 GMP and GDP.
• Familiarity with QMS and regulatory requirements in medical device industry.

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 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 records management.

Skills

Attention to detail

Communication

Independent work

GMP knowledge

GDP knowledge

Education

High school diploma or technical school education

Tools

Oracle

Agile

Job description

Manufacturing Data Coordinator

Why Hologic

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.

What to Expect

• 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.

What we expect:

• 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.

Qualifications

Education and Experience

• 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).trong organizational skills to maintain accurate records, logs, and reports.Commitment to continuous improvement and operational excellence.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
• 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

The annualized base salary range for this role is $ $46,400- $69,600and is bonus eligible. Final compensation packages will depend on factors such as experience, skills, knowledge, location, education, business needs, and market demand.

Hologic is an equal opportunity employer inclusive of females, minorities, individuals with disabilities, and veterans (M/F/D/V).

Additional Information

#LI-JW2

Same posting description for internal and external candidates.