Quality Systems Manager
Medbio, Inc., Grand Rapids, MI, United States
Job Category:
Operations , Production , Quality
Schedule:
1st Shift
Location:
Grand Rapids, MI , Orchard Park, NY , Schoolcraft, MI
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.
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
Qualifications
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
Salary range: $110,000-$135,000 annually
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Operations , Production , Quality
Schedule:
1st Shift
Location:
Grand Rapids, MI , Orchard Park, NY , Schoolcraft, MI
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.
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
Qualifications
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
Salary range: $110,000-$135,000 annually
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