Onsite Quality Manager – Medical Devices

Cardinal Health, Inc.; Weymouth (MA); On-site; USD 107,000 - 152,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Onsite work environment

Disability coverage

Job summary

Cardinal Health, Inc. is seeking a Quality Manager/Engineer to lead quality policies, audits, and regulatory compliance in a medical device manufacturing environment.

You will collaborate with engineering, production, and supply chain teams to ensure product quality and patient safety. The role emphasizes risk management, CAPA, document control, and preparing the site for FDA and ISO 13485 inspections, while coaching staff and guiding KPI-driven improvements.

Qualifications

• Minimum 3 years of experience in a quality manager or quality engineer role for a medical device manufacturing company preferred.
• Minimum 4 years of leadership experience in managing both hourly and salary professionals preferred.
• Experience with root cause analysis, corrective actions and documentation control preferred.
• Bachelor’s degree in related field, preferred or equivalent work experience

Responsibilities

• Develop and implement quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
• Provide strategic oversight, leadership and direction to direct reports within the Quality function.
• Manage, develop, train and guide direct reports, quality staff, and site personnel to achieve site quality goals and maintain regulatory compliance.
• Lead audit readiness efforts and facilitate regulatory, customer and corporate audits such as (FDA and MDSAP) and customer technical visits and provide responses to findings in a timely manner.
• Conducting Site Quality Management Reviews and report KPI metrics to corporate.
• Responsible for identifying trends and making decisions that affect product release to ensure patient safety.
• Responsible for understanding ISO 13485, FDA QSR and other relevant standards and to apply them to continuous improvement of the Quality Management System.
• Manage internal audits, external audits, and regulatory inspections.
• Oversee document control, CAPA (Corrective and Preventive Actions), NCR (Non-Conformance Reports), and complaint handling in a manufacturing environment.
• Support risk management activities, including hazard analysis and FMEA.
• Ensure quality oversight throughout product lifecycles from design control and supplier qualification to manufacturing and post-market surveillance.
• Collaborate with engineering, production, and supply chain teams to ensure product quality and process compliance.
• Train and mentor staff on quality procedures and regulatory requirements.
• Lead root cause analysis and problem-solving initiatives for quality issues.
• Analyze quality metrics and identify trends for escalation to senior management as required.

Skills

Quality management

Leadership

Root cause analysis

Documentation control

Education

Bachelor's degree in related field

Job description

Cardinal Health, Inc. is seeking a Quality Manager/Engineer to lead quality policies, audits, and regulatory compliance in a medical device manufacturing environment.

You will collaborate with engineering, production, and supply chain teams to ensure product quality and patient safety. The role emphasizes risk management, CAPA, document control, and preparing the site for FDA and ISO 13485 inspections, while coaching staff and guiding KPI-driven improvements.