ISO Compliance Leader – Manufacturing & Audits

Crawford Thomas Recruiting; Watertown (MA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Life insurance

401(k)

Retirement plan

Employee discounts

Flexible schedule

Job summary

Crawford Thomas Recruiting client in Watertown, MA seeks a Compliance Manager to oversee the quality management system, maintain certification readiness, and ensure procedures align with ISO 13485 and ISO 9001.

This on-site role emphasizes audits, CAPA, document control, training records, and continuous improvement, with collaboration across production, engineering, and leadership to strengthen process controls.

Qualifications

• Manufacturing experience with direct responsibility for a quality management system.
• Strong working knowledge of ISO 13485 and ISO 9001.
• Experience preparing for and participating in internal and external audits.
• Hands-on experience with CAPA, document control, controlled records, and training documentation.
• Experience developing, implementing, and improving procedures and process controls.
• Understanding of root-cause analysis and continuous-improvement methods.
• Ability to translate compliance requirements into practical manufacturing procedures.
• Strong organizational, communication, documentation, and follow-through skills.
• Ability to collaborate effectively across production, engineering, maintenance, and management.
• Engineering, manufacturing, quality, or related degree preferred; equivalent professional experience will be considered

Responsibilities

• Maintain compliance with ISO 13485 and ISO 9001 requirements.
• Keep the organization prepared for certification, customer, and regulatory audits.
• Plan and coordinate internal and external audit activities.
• Document audit findings and ensure corrective actions are completed on time.
• Manage the quality management system and its supporting procedures.
• Oversee document control, including revisions, approvals, distribution, and retention.
• Lead CAPA activities involving investigations, root-cause analysis, corrective actions, and effectiveness reviews.
• Ensure employee training records and required compliance documentation remain accurate and current.
• Verify that nonconforming material, equipment maintenance, and other controlled records are complete.
• Partner with production, engineering, maintenance, and leadership to improve procedures and process controls.
• Identify compliance risks and recommend corrective or preventive measures.
• Help employees understand and consistently follow documented processes.
• Support workplace safety procedures, required training, and related documentation.
• Monitor compliance performance and recommend continuous-improvement initiatives.
• Communicate requirements clearly across departments and provide guidance when questions arise.

Skills

ISO 13485 knowledge

ISO 9001 knowledge

Audit coordination

CAPA management

Document control

Training documentation

Root-cause analysis

Continuous improvement

Cross-functional collaboration

Compliance documentation

Education

Engineering/Manufacturing/Quality degree preferred

Tools

Document management system

CAPA software

Job description

Crawford Thomas Recruiting client in Watertown, MA seeks a Compliance Manager to oversee the quality management system, maintain certification readiness, and ensure procedures align with ISO 13485 and ISO 9001.

This on-site role emphasizes audits, CAPA, document control, training records, and continuous improvement, with collaboration across production, engineering, and leadership to strengthen process controls.