What are the responsibilities and job description for the Quality System Manager position at Medbio, LLC?
Summary of Function:
The Quality Systems Manager is responsible for maintaining and continuously improving the Quality Management System (QMS) in compliance with ISO 13485 and applicable regulatory requirements. This role supports multiple manufacturing sites, ensuring consistent quality standards, regulatory compliance, and effective quality processes across the organization.
Major Duties and Responsibilities:
Quality Management System (QMS)
- Maintain and improve the QMS in compliance with ISO 13485 and applicable regulatory standards
- Own and manage core QMS processes, including:
- CAPA (Corrective and Preventive Actions)
- Non-Conforming Product (NCP)
- Complaint Handling
- Ensure effective workflow, system definition, and process standardization across all sites.
- Drive continuous improvement initiatives using quality metrics and data analysis.
Cross-Functional & Multi-Site Support
- Collaborate with manufacturing, engineering, regulatory, and operations teams across all sites.
- Standardize processes and ensure alignment across locations.
- Provide leadership and guidance on quality-related matters.
Document & Change Control
- Administer the document control system, ensuring accuracy, revision control, and compliance.
- Manage Engineering Change Orders (ECO) and quality system changes.
- Oversee updates and configuration of quality management software systems.
Audit & Compliance
- Maintain the external audit program across multiple sites manage and support internal local site audit coordination.
- Ensure readiness and compliance with regulatory bodies and notified bodies.
- Support and lead:
- Internal audits
- Customer audits
- Regulatory inspections
- Drive timely and effective corrective action responses.
Validation & Qualification
- Define and oversee qualification protocols, including standardization of:
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Performance Qualification)
- Ensure validation activities meet regulatory and internal requirements.
Customer Quality & Compliance
- Manage customer quality requirements, including:
- Quality agreements
- Surveys and questionnaires
- Customer-specific compliance needs
- Act as a quality liaison for customer-related issues and escalations as required.
Training & Development
- Support the development and delivery of QMS training programs.
- Ensure personnel are trained and compliant with quality procedures and regulatory standards.
- Promote a culture of quality and continuous improvement.
Supplier & Vendor Quality
- Partner with Supply Chain to:
- Qualify new vendors
- Maintain approved supplier lists
- Monitor supplier performance
- Support supplier audits and ensure supplier compliance with quality requirements.
Key Performance Indicators (KPIs)
- CAPA closure time and effectiveness
- Audit findings and closure timelines
- Supplier quality performance
- Complaint resolution time
- Training compliance rates
- QMS effectiveness metrics
Experience and/or Educational Requirements:
Education
- Bachelor’s degree in Engineering, Life Sciences, or related field (required)
Experience
- 5 years in Quality within medical device manufacturing, plastics molding preferred
- Experience with multi-site quality systems (strongly preferred)
- Hands-on experience with ISO 13485 and regulatory audits
Skills
- Strong knowledge of QMS processes and regulatory requirements
- Experience with quality systems software
- Excellent problem-solving and root cause analysis skills
- Strong communication and cross-functional leadership abilities