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BSI Group

ISO 18081,000 1901ISO90 ISO 13485 QMS （MUST） （） ＊ （） ＊ （） （WANT） / ＊ＢＳＩ ：（） ＊ISO13485 ：9：00～17：30（60） ：14（） ： ：（1）（60） Medical ...

BSI Prof Serv EHS West

ISO 18081,000 1901ISO90 ISO 13485 QMS （MUST） （） ＊ （） ＊ （） （WANT） / ＊ＢＳＩ ：（） ＊ISO13485 ：9：00～17：30（60） ：14（） ： ：（1）（60） Medical ...

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How much do iso 13485 jobs pay per hour?

As of Aug 27, 2026, the average hourly pay for iso 13485 in the United States is $21.09, according to ZipRecruiter salary data. Most workers in this role earn between $18.27 and $21.63 per hour, depending on experience, location, and employer.

What is an ISO 13485?

An ISO 13485 job typically involves roles in quality management, regulatory compliance, and manufacturing within the medical device industry. Professionals in these roles ensure that companies adhere to ISO 13485, the international standard for quality management systems in medical devices. Responsibilities may include managing audits, maintaining documentation, overseeing regulatory compliance, and improving quality processes. These jobs are crucial for ensuring product safety, consistency, and compliance with regulatory requirements.

What are the typical day-to-day responsibilities of someone working in an ISO 13485 quality assurance role?

Professionals in an ISO 13485 quality assurance role are typically responsible for developing, implementing, and maintaining quality management systems specific to medical devices. Their daily tasks include preparing documentation, conducting internal audits, ensuring compliance with regulatory standards, managing nonconformances, and coordinating corrective actions. They often collaborate closely with engineering, manufacturing, and regulatory affairs teams to address quality issues and facilitate continuous improvement. This position involves significant attention to detail and communication to uphold the organization’s quality objectives and regulatory commitments.

What are the key skills and qualifications needed to thrive in the ISO 13485 position, and why are they important?

To thrive in an ISO 13485 role, you need a strong understanding of quality management systems for medical devices, regulatory requirements, and risk management principles, often supported by a background in engineering, life sciences, or quality assurance. Familiarity with audit processes, CAPA (Corrective and Preventive Action) systems, and certifications like Certified Quality Auditor (CQA) or ISO 13485 Lead Auditor are highly valued. Attention to detail, problem-solving abilities, and effective communication set outstanding candidates apart. These skills ensure compliance with stringent regulations and help maintain product quality and patient safety in the medical device industry.

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Iso 13485 jobs near you
Infographic showing various Iso 13485 job openings in the United States as of August 2026, with employment types broken down into 91% Full Time, 2% Part Time, 5% Contract, and 2% Nights. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $43,861 per year, or $21.1 per hour.

Quality Manager - Medical Device/ ISO 13485

Vonco Products LLC

Trevor, WI • On-site

Full-time

Posted 12 days ago

Job description

Job Type
Full-time
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.

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