About the Role
The Quality Manager will coordinate inspections and the proper integration of quality tools to improve existing processes, support manufacturing product conformance, and support new product development activities.
Key Activities
Ensures continual compliance with quality management system processes and improvement, including ISO 9001, ISO13485, AS9100, ISO14971, customer, regulatory, and statutory requirements.
As the selected management representative, ensures that processes needed for the quality management system are documented, reports to top management on the effectiveness of the quality management system and any need for improvement, and ensures the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organisation.
Drives corrective action and root cause closures of failure events for such audits that require corrective actions, findings from internal audits and customer audits. Be the point person for all internal and customer audits (ISO Management Representative).
Manage department personnel and coordinate internal resources to support department activity (calibration, return material authorisation, first article, gauge R&Rs, incoming inspection, in-process inspection, VQC, electrical inspection and statistical process control).
Initiates the development and improvement of (and/or improves new) practices and procedures to promote data collection and in-process inspection in the manufacturing work centres and within the Quality Assurance department activities.
Initiates the development of supplier quality metrics, maps critical supplier performance trends, supplier auditing and provides feedback in advance of non-conforming material events; participates in supplier audits and supplier improvement projects.
Provide support to product development activities through facilitation of the Process Failure Mode and Analysis tool and development of product-specific inspection plans.
Promote an awareness of Quality Assurance goals and processes throughout operations and create an environment committed to continuous quality improvement.
Some travel may be required.
Preferred Skills
ISO 9001 and AS9100 lead auditor.
Advanced Product Quality Planning (APQP).
Education and Experience
Bachelor’s degree in quality, manufacturing, engineering, business, or equivalent experience.
Minimum of 10 years of quality manufacturing experience.
5+ years of people leadership experience.
Thorough knowledge of ISO 13485 qualification and certification.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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