Manufacturing Data Coordinator
Hologic, Inc. · Marlborough, MA · 2 wk ago
Information TechnologyFull-time
About the role
The Manufacturing Data Coordinator plays a crucial role in ensuring the quality and compliance of finished products in Hologic's manufacturing processes. This position requires a high level of attention to detail and adherence to strict documentation standards.
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.
Qualifications
- 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.
Pay
The annualized base salary range for this role is $46,400-$69,600 and is bonus eligible. Final compensation packages will depend on factors such as experience, skills, knowledge, location, education, business needs, and market demand.
Schedule
Flexible schedule to accommodate the needs of the role and the organization.