Manufacturing Data Coordinator

Hologic, Inc.; Marlborough (MA); In loco; USD 46.400 - 69.600; Tempo pieno

Descrizione del lavoro

Hologic, Inc. is seeking an experienced quality inspector in Marlborough, MA. This role involves detailed documentation reviews, ensuring GMP compliance, and supporting production lines. Candidates must have a high school diploma and 3–5 years in medical manufacturing quality inspection.

The position offers a salary range of $46,400-$69,600 and is bonus eligible. Hologic promotes a diverse workplace inclusive of all individuals.

Competenze

• Minimum of 3–5 years of related quality inspection experience in a medical manufacturing environment.
• Strong attention to detail and accuracy in documentation review.
• Ability to work independently and make informed decisions.

Mansioni

• Perform detailed reviews of Device History Records (DHRs).
• Communicate Good Manufacturing Practices (GMP) to personnel.
• Generate folders and labels for manufacturing.

Conoscenze

Attention to detail

Interpersonal skills

Communication skills

Quality tools proficiency

Formazione

High school diploma or equivalent technical school education preferred

3–5 years of related quality inspection experience

Strumenti

Oracle

Agile

Descrizione del lavoro

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).
• 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).