QA Manager
QA Manager
Responsibilities
• Lead the QA/RA function and drive organizational excellence •
Work with other functions to implement and maintain programs and processes to ensure highquality products and compliance with ISO 9001
• Oversee the maintenance and improvement of an ISO 9001-compliant Quality System
• Create, revise, review, and approve quality-related documents, including but not limited to procedures, memoranda, protocols, batch records, and reports
• Support the creation of incoming QC methods and supervise their performance
• Supervise the reviews of manufacturing, and quality control data for in-process and finished products to comply with relevant standards
• Responsible for the enforcement of quality standards and process controls
• Responsible for the management and coordination of training, equipment calibration, and maintenance programs
• Responsible for the customer complaint, non-conformance and CAPA processes, and MRBs
• Lead the supplier evaluation and approval process
• Lead and participate in the management reviews of the quality system. Elicit input from other departments
• Lead the preparation, coordination, and management of inspections and audits
• Elicit cooperation from cross-functional team members in assuring readiness for, and responses to, audit findings
• Oversee, review, and approval of product design control process and documents
• Maintain a working knowledge of applicable government and industry quality standards
• Multitask and manage competing priorities while meeting production timelines
• Bachelor’s Degree in a discipline appropriate to Quality Assurance management
• Professional certification, such as Quality Engineer, or Quality Auditor
• 5+ years of experience in an ISO9001/AS9100 environment, 3 of which were in a Quality role; 2 years of management experience in quality for a Manager position
• Specific experience with electromechanical devices/components
• Demonstrates in-depth knowledge of QA principles, concepts, industry best practices, and standards
• Demonstrates knowledge of testing best practices, version control practices, defect management practices, Risk Management systems and tools, and/or Failure Mode Effects Analysis (FMEA)
• Experience with global Contract Manufacturers, Suppliers, and Customers • Superb competence with MS Office, SolidWorks, PDM, Agile, and Priority ERP Software
• Analytical, problem-solving mindset, and decision-making skills
• Close attention to detail
• Demonstrates excellent verbal, written, and interpersonal communication skills
• Excellent teamwork
• Able to work independently and self-motivated
• Advanced English proficiency
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