Description

Quality Manager | ISO 13485 Medical Device Manufacturing

We are seeking a hands-on Quality Manager who can lead and continuously improve our ISO 13485 Quality Management System while supporting a fast-paced medical device packaging manufacturing operation. This individual will serve as the site quality leader, partnering closely with Operations, Engineering, Supply Chain, and Customer Service to ensure compliance, drive continuous improvement, and maintain customer confidence.

The ideal candidate is a proactive quality leader with experience in medical devices, healthcare packaging, or other regulated manufacturing environments. They are comfortable balancing strategic quality system oversight with day-to-day operational support and can effectively influence cross-functional teams.

Basic Purpose and Function: The Quality Manager is responsible for developing, implementing, maintaining, and continuously improving the organization's Quality Management System (QMS) in accordance with ISO 13485, applicable regulatory requirements, customer requirements, and company objectives.

This position serves as the site's management representative for the Quality Management System. It ensures that product realization activities, risk management processes, supplier controls, CAPA activities, and post-market quality processes effectively support the manufacture of safe and effective medical devices.

The Quality Manager partners closely with Operations, Engineering, Supply Chain, and Customer Service teams to ensure compliance while driving a culture of quality and continuous improvement.

Job Responsibilities:

Quality Management System (QMS)

Manage and maintain the ISO 13485 Quality Management System.
Ensure compliance with all applicable regulatory and customer requirements.
Oversee document control and record retention processes.
Coordinate Management Review activities and present quality system performance metrics.
Ensure quality objectives are established, monitored, and achieved.
Maintain inspection readiness and audit preparedness.

CAPA and Nonconformance Management

Lead the Corrective and Preventive Action (CAPA) program.
Ensure timely investigation and closure of quality issues.
Facilitate root cause investigations.
Monitor effectiveness of corrective actions.
Manage nonconforming product processes and disposition activities.

Risk Management

Ensure risk management activities comply with ISO 14971 requirements.
Participate in risk assessments associated with products, processes, equipment, and suppliers.
Support implementation of risk controls and verification of effectiveness.
Ensure risk management files remain current and complete.

Validation and Quality Engineering Support

Review and approve validation protocols and reports.
Support process improvement and process capability initiatives.
Ensure manufacturing changes are properly evaluated and validated.

Internal Audits and Regulatory Inspections

Manage the internal audit program.
Coordinate external audits, customer audits, certification audits, and regulatory inspections.
Track audit findings through closure.

Supplier Quality Management

Ensure supplier qualifications and monitoring programs meet ISO 13485 requirements.
Manage supplier audits and supplier performance reviews.
Oversee supplier corrective action requests (SCARs).
Support supplier risk assessments and change management.

Customer Quality and Complaint Handling

Manage customer complaint investigations.
Ensure complaint-handling processes meet applicable regulatory requirements.
Analyze customer quality trends and implement improvement actions.
Serve as primary escalation point for customer quality issues.

Training and Quality Culture

Ensure employee training programs meet regulatory and quality requirements.
Verify personnel competency for quality-critical tasks.
Promote quality awareness throughout the organization.
Support continuous improvement initiatives across all departments.

Leadership Responsibilities

Lead and develop Quality Specialists, Technicians, Auditors, and Inspectors.
Establish departmental goals and objectives.
Manage department resources.
Provide quality guidance to Operations, Engineering, and Customer Service.

Success Measures

Successful maintenance of ISO 13485 certification
Timely closure and effectiveness of CAPAs
Reduction in customer complaints and internal quality issues
Successful completion of internal, customer, and certification audits
Supplier quality performance improvements
On-time completion of Management Reviews and Quality Objectives

Requirements

Required Background

Bachelor’s degree in engineering, Quality, Manufacturing, Life Sciences, or related field.
5+ years of progressive quality experience in a regulated manufacturing environment.
3+ years working with ISO 13485 Quality Management Systems.
Experience leading internal, customer, and certification audits.
Strong knowledge of CAPA, nonconformance management, change control, complaint handling, and supplier quality.
Experience in FDA-regulated manufacturing is highly preferred.

Key Characteristics

Strong leadership presence with the ability to coach and develop quality personnel.
Highly organized and detail-oriented.
Effective communicator who can build credibility across all levels of the organization.
Skilled problem solver with root cause analysis experience.
Comfortable making risk-based decisions in a regulated environment.
Able to balance compliance requirements with operational realities.

Technical Expertise: demonstrated experience with:

ISO 13485
CAPA systems
Internal auditing
Risk management (ISO 14971 preferred)
Supplier qualification and supplier corrective actions
Validation activities (IQ/OQ/PQ)
Complaint investigations
Document control and change management

Physical Requirements

· Reaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing, and repetitive motions.

· This position frequently requires the use of hands to handle or feel objects, tools, or controls, and to reach with hands and arms.

· The associate must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this job include close vision and the ability to adjust focus.