QMS Manager
Day to day:
Responsible for the US portion QMS Act as a trusted advisor to internal stakeholders in responding to customers, FDA and state agencies Collaborate with internal stakeholders to drive formalization and implementation of management system plans.
Execute plans to effectively monitor and implement product field corrections and recalls.
Take ownership of SSU projects that integrate quality & regulatory with business objectivesQuality Management:
Maintenance and development of the quality management system in accordance with Global QMS and FDA regulations including document and record control Develop and maintain internal operating policies and procedures relating to regulatory and quality activities applicable to US SSU organization.
Oversee and report to NA SSU management on quality and compliance issues in relation to the product and its labeling, process or quality system deficiencies.
Lead CAPA Board and conduct or direct the internal investigation of compliance issues within CAPA System.
Deliverables include publishing quality metrics as governed by corporate procedures.
Drive completion of MSPs (Management System Plans opened for various business functions).
Manage quality training for staff in SSU US.
This includes planning, preparing and delivering periodic regulatory/quality training to internal groups as needed or required.
Conduct periodic internal audits to ensure that compliance procedures are followed within US SSU organization.
Quality Systems
Responsibilities:
Support harmonization of SSU core processes and interfaces.
Liaise with all department managers to assure that relevant processes are documented and subsequent documents are established, reviewed and approved and that applicable personnel receive documented training.
Support controls of suppliers incl.
participation in supplier audits and establishing quality agreements.
Support controls of distributors, including establishing quality agreements.
Lead and coordinate preparation and follow-up on SSU US Management Reviews Conduct annual Performance Reviews, Bonus Plan development and reviews.
Talent Management of up, coming individuals, and succession planning.
Induct new employees, conduct monthly Probation Reviews.
Plusses:
Manufacturing Background Must haves:
Bachelor's Degree 7
years of quality background in Medical Devices 1-2 years of Management experience in the industry - Supplier Quality/Complaint Handling Group Full on Quality Mgmt System Compliance experience Thorough knowledge of applicable procedures and regulations of 21 CFR 820, 806 & 803 Thorough knowledge of ISO13485 Recommended Skills Auditing Business Planning Food Safety Iso 13485 Standard Labeling Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
Responsible for the US portion QMS Act as a trusted advisor to internal stakeholders in responding to customers, FDA and state agencies Collaborate with internal stakeholders to drive formalization and implementation of management system plans.
Execute plans to effectively monitor and implement product field corrections and recalls.
Take ownership of SSU projects that integrate quality & regulatory with business objectivesQuality Management:
Maintenance and development of the quality management system in accordance with Global QMS and FDA regulations including document and record control Develop and maintain internal operating policies and procedures relating to regulatory and quality activities applicable to US SSU organization.
Oversee and report to NA SSU management on quality and compliance issues in relation to the product and its labeling, process or quality system deficiencies.
Lead CAPA Board and conduct or direct the internal investigation of compliance issues within CAPA System.
Deliverables include publishing quality metrics as governed by corporate procedures.
Drive completion of MSPs (Management System Plans opened for various business functions).
Manage quality training for staff in SSU US.
This includes planning, preparing and delivering periodic regulatory/quality training to internal groups as needed or required.
Conduct periodic internal audits to ensure that compliance procedures are followed within US SSU organization.
Quality Systems
Responsibilities:
Support harmonization of SSU core processes and interfaces.
Liaise with all department managers to assure that relevant processes are documented and subsequent documents are established, reviewed and approved and that applicable personnel receive documented training.
Support controls of suppliers incl.
participation in supplier audits and establishing quality agreements.
Support controls of distributors, including establishing quality agreements.
Lead and coordinate preparation and follow-up on SSU US Management Reviews Conduct annual Performance Reviews, Bonus Plan development and reviews.
Talent Management of up, coming individuals, and succession planning.
Induct new employees, conduct monthly Probation Reviews.
Plusses:
Manufacturing Background Must haves:
Bachelor's Degree 7
years of quality background in Medical Devices 1-2 years of Management experience in the industry - Supplier Quality/Complaint Handling Group Full on Quality Mgmt System Compliance experience Thorough knowledge of applicable procedures and regulations of 21 CFR 820, 806 & 803 Thorough knowledge of ISO13485 Recommended Skills Auditing Business Planning Food Safety Iso 13485 Standard Labeling Leadership Estimated Salary: $20 to $28 per hour based on qualifications.
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