QMS Resource Consultant - OQSIE
Ramsey, NJ, MD
About the Job
Supplier Quality Manager for six (6) month min @ Hunt Valley MD
Key Responsibilities
The primary responsibilities of the Supplier Quality Manager will be to manage, and maintain the Supplier Quality Program including:
• Implementing a Reduced Testing Program
• Manage a risk based Supplier Quality Audit program
• Qualification and re-qualification of suppliers including conducting supplier audits
• Supplier monitoring and scorecard tracking
• Handling and coordination of Non-Conforming Material (MRB) process controls and communication actions including Supplier Corrective Action Requests (SCARs) to suppliers
• Support of New Product Development in the qualification of new suppliers and qualification of new parts
• Support Quality Management System that establishes and maintains effective quality assurance processes and compliance to the International Standard: ISO13485, Canadian Medical Device Regulations (CMDR, SOR 98-292), FDA Quality System Regulations (QSR, 21 CFR Part 820) and the Medical Device Directive (MDD93/42/EEC)
• Manage the Supplier Corrective Action Request (SCAR) process
• Deals directly with our customers and vendors to ensure compliance with quality requirements
• Participate in Quality Management System (QMS) process improvements including kaizen and other lean events
Knowledge, Skills, And Abilities
• Skill in analytical problem solving, root cause analysis, and driving corrective actions required
• Experience and aptitude Quality Management System Lead Auditor required
• ASQ Certification, such as Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA) is preferred
• Ability to work under time constraints to meet strategic objectives
• Ability to prioritize effectively and focus on results
• Ability to handle strong opposition is required
• Professional interpersonal and communication skills
Key Responsibilities
The primary responsibilities of the Supplier Quality Manager will be to manage, and maintain the Supplier Quality Program including:
• Implementing a Reduced Testing Program
• Manage a risk based Supplier Quality Audit program
• Qualification and re-qualification of suppliers including conducting supplier audits
• Supplier monitoring and scorecard tracking
• Handling and coordination of Non-Conforming Material (MRB) process controls and communication actions including Supplier Corrective Action Requests (SCARs) to suppliers
• Support of New Product Development in the qualification of new suppliers and qualification of new parts
• Support Quality Management System that establishes and maintains effective quality assurance processes and compliance to the International Standard: ISO13485, Canadian Medical Device Regulations (CMDR, SOR 98-292), FDA Quality System Regulations (QSR, 21 CFR Part 820) and the Medical Device Directive (MDD93/42/EEC)
• Manage the Supplier Corrective Action Request (SCAR) process
• Deals directly with our customers and vendors to ensure compliance with quality requirements
• Participate in Quality Management System (QMS) process improvements including kaizen and other lean events
Knowledge, Skills, And Abilities
• Skill in analytical problem solving, root cause analysis, and driving corrective actions required
• Experience and aptitude Quality Management System Lead Auditor required
• ASQ Certification, such as Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), Certified Quality Auditor (CQA) is preferred
• Ability to work under time constraints to meet strategic objectives
• Ability to prioritize effectively and focus on results
• Ability to handle strong opposition is required
• Professional interpersonal and communication skills
Source : OQSIE