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Quality Manager
1 month ago
Quality Manager - San Carlos, California
Advantage Converting is a dynamic manufacturing company with over 40 years of experience providing superior quality components and solutions to medical, electronics, green energy and industrial customers. We are creative thinkers and problem solvers. Come join our team
This position is responsible for the implementation, monitoring and compliance to the Company’s Quality Management System (QMS), management of all audits, regulatory requirements and safety regulations to ensure the operations activities meet company business flow and customer needs.
Responsibilities
Manage the implementation and maintenance of the QMS in compliance with ISO 13485 and customer contractual agreements
Manage all aspects of internal and external audits, including customer, supplier and registrar certifications
Manage Quality Technicians who perform First Articles, In Process and Final Inspections, spotcheck product and documentation
Support supplier management activities, including supplier evaluation, audits, material non-conformances and quality metrics
Gather data, report, and facilitate actions as identified on organizational KPIs
Manage customer complaints, issues and non-conformances, conduct Root Cause Analysis and drive CAPA activities
Manage clean rooms and ensure testing is performed in support of the QMS, regulations, customer and business needs
Manage equipment qualifications and Process Validations
Partner with senior leadership to develop and execute overall service and quality program strategies and metrics as they pertain to product quality, reliability and safety. Manage and contribute to customer driven quality related projects
Collaborate across all departments to implement corrective actions and process improvements.
Research and recommend new technologies, practices and systems that could help the overall operation and business flow in relation to quality management
Work closely with manufacturing and the management team to assess and mitigate risks associated with manufacturing processes, safety, product quality and delivery
Support the creation of, monitoring and conducting of training needs across the organization as it relates to Quality, Safety, Productivity and Compliance
Perform other duties and responsibilities as necessary
Required Education & Experience
Bachelor’s degree preferably related to manufacturing, medical device, business management or engineering discipline
Extensive experience in a Quality leadership role in manufacturing (preferably medical device component and finished product) or precision or technical component manufacturing environment
Four years of training in and managing Quality Management Systems
Three years successfully managing all facets of customer and supplier audits and ISO 13485 certification
Experience leading Root Cause Analysis, Corrective and Preventive Action (CAPA), performing investigations using investigational tools
Experience with inspection equipment and able to read, interpret and explain engineering drawings and specifications
Excellent communication skills and extremely organized, experienced in training
Demonstrated ability to work independently with limited direction
Able to work full time on site
Employee Benefits
Medical, dental and vision
401(k) plan with employer match
Paid vacation, sick, and holidays
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