Kitting & Device Manufacturing Operations Specialist

Foundation Medicine, Inc.; Morrisville (NC); On-site; USD 77,000 - 97,000; Full time

Job summary

Foundation Medicine, Inc. in Boston, MA is seeking an Operations Specialist, Device Manufacturing to ensure compliant and timely execution of device manufacturing and kitting activities.

You will manage work orders, documentation, labeling, and release coordination while supporting cross-functional process improvements. The role requires deep knowledge of quality systems, GMP, documentation practices, and experience in regulated settings, with onsite work and collaboration across teams.

Qualifications

• High school diploma with 7 years of relevant experience, or Associate degree with 5 years, or Bachelor’s degree with 3 years of relevant experience
• 2+ years of experience in a regulated manufacturing, medical device, diagnostics, biotechnology, pharmaceutical, laboratory, or comparable environment
• Familiarity with ERP systems such as SAP, Oracle, JD Edwards, NetSuite, Maximo, or comparable platforms

Responsibilities

• Regular onsite work at a FMI location is an essential function of the role.
• Lead and perform kitting activities in accordance with approved procedures, specifications, and manufacturing records.
• Sequence assigned work, confirm production readiness, and communicate material, capacity, quality, or documentation risks.
• Execute and document kit assembly, packaging, labeling and reconciliation, verification, inventory transactions, release activities, and rework.
• Generate and maintain work orders, Device History Records, and supporting production documentation, and accurately record production and material transactions in approved ERP and manufacturing systems.
• Review manufacturing records for accuracy, completeness, traceability, and compliance.
• Serve as the kitting subject-matter expert and author or revise associated procedures, work instructions, forms, and training materials.
• Identify and elevate potential quality events; pause work and protect affected material or product when quality or compliance may be at risk.
• Support investigations, change controls, risk assessments, validation, audits, product introductions, system changes, and process improvements.
• Train and cross-train colleagues, maintain required qualifications, and develop proficiency in additional Device Manufacturing workflows to support operational continuity.
• Collaborate with cross-functional partners, comply with FMIs attendance policies, and complete other duties appropriate to the role.
• Comply with FMI's attendance policies

Skills

Kitting

Documentation

Manufacturing operations

Quality systems

Regulated environment

Cross-functional collaboration

Education

Bachelor's degree in engineering / supply chain / operations

Tools

SAP, Oracle, JD Edwards, NetSuite, Maximo

Job description

Foundation Medicine, Inc. in Boston, MA is seeking an Operations Specialist, Device Manufacturing to ensure compliant and timely execution of device manufacturing and kitting activities.

You will manage work orders, documentation, labeling, and release coordination while supporting cross-functional process improvements. The role requires deep knowledge of quality systems, GMP, documentation practices, and experience in regulated settings, with onsite work and collaboration across teams.