Quality Assurance Manager

Enfield, CT

As a Supplier Quality Manager (SQM), you will play a crucial role in ensuring that the quality of our regional purchased materials, OEM products, and service providers meets our standards. You will be responsible for overseeing the qualification, development, integration, monitoring, and auditing of suppliers, as well as driving continuous improvement initiatives. Your role will also involve supporting the product design and development process, maintaining compliance with relevant standards, and optimizing supplier performance.

Key Responsibilities:

Supplier Quality Management:

• Ensure the quality levels of regional purchased materials, OEM products, and service providers through effective qualification, development, integration, monitoring, and auditing.
• Oversee the readiness of regional suppliers in terms of quality early in the development process to ensure seamless integration.

Product Design & Development Support:

• Collaborate with regional product design and development teams to address specification, risk management, validation, and control of supplier-related aspects.
• Support the selection, evaluation, and qualification of materials, products, and service providers to ensure stable operation processes.

Continuous Improvement:

• Drive continuous improvement initiatives using quality methods and best practices.
• Define, implement, and refine quality technical tools, processes, and systems to support the effective execution of the Quality Management (QM) system.

Compliance & Standards:

• Ensure and enhance compliance with ISO 9001, ISO 13485, US FDA 21 CFR Part 820, and GMP standards, as applicable.
• Manage material compliance processes, including validation and release of material compliance certificates.

Quality Planning & Risk Management:

• Define and monitor engineering and material specifications, including material risk failure assessments, in close collaboration with R&D and suppliers.
• Advance quality planning and quality assurance for critical materials.

Supplier Development & Audits:

• Plan, coordinate, and conduct supplier audits to assess quality and manufacturing capabilities.
• Support the supplier qualification, surveillance, and development programs.
• Define inspection criteria and test procedures based on development specifications and supplier agreements.

Complaint Resolution & KPIs:

• Review and address supplier complaints, including escalation and resolution of systematic issues.
• Develop, execute, and analyze supplier quality KPIs to report on quality issues, trends, and losses.

Global Initiatives & Negotiations:

• Support global initiatives as requested and negotiate Corporate Standard Quality Assurance Agreements with suppliers.
• Assist with the supplier selection process, including evaluation and development, in collaboration with Forward Sourcing and Category Managers.

Your Expertise:

• Degree in Business Engineering, Mechanical Engineering, Chemistry, Physics, or a related field.
• Several years of experience in supplier quality management, technical construction, or technical procurement.
• In-depth knowledge of quality management principles and practices.
• Proven experience in quality by design within a high-tech manufacturing environment.
• Strong technical understanding, preferably in electronics, polymers, or mechanical processing.
• Extensive experience in process optimization and quality management.
• Proficiency in MS Office and SAP.
• Business fluency in English.
• Willingness to travel regionally and internationally as required.