Quality Assurance Lead

Position Summary

We are looking to hire a meticulous Quality Assurance Lead to manage all facets of quality assurance and control within our compact engineering firm. This role is pivotal in ensuring our products and processes not only meet but surpass customer expectations and regulatory mandates while promoting a culture of continual enhancement. The Quality Lead will collaborate closely with multiple departments to uphold quality benchmarks and improve operational efficiencies across the board.

Key Responsibilities

• Design, deploy, and maintain the company’s quality management system (QMS).
• Set down clear quality standards, procedures, and product/process specifications.
• Perform inspections, audits, and tests to verify adherence to quality and regulatory standards.
• Investigate and resolve quality challenges including non-conformities, customer grievances, and process irregularities.
• Manage supplier quality ensuring raw materials comply with specifications.
• Coordinate and lead Management Reviews of the Quality System ensuring all departments deliver effective services to customers.

Supply Chain Quality

• Handle quality matters related to customers and suppliers promptly and efficiently.
• Collaborate with suppliers to enhance the quality of incoming materials.
• Manage the customer complaint procedures, perform root cause analyses, and implement Corrective and Preventive Actions (CAPA).

Process Improvement

• Spot opportunities to improve product and process quality.
• Lead projects utilizing Lean, Six Sigma, or other continuous improvement practices.
• Work together with engineering and production teams to optimise workflows and reduce waste.
• Set and track key performance indicators (KPIs) to monitor quality outcomes.

Leadership and Collaboration

• Provide training and guidance on quality processes and best standards to employees.
• Act as the main contact for quality concerns from customers and regulatory bodies.
• Encourage organisation-wide responsibility for quality and accountability.
• Prepare and deliver quality performance reports for management review, emphasizing trends and improvement suggestions.

Compliance and Documentation

• Maintain compliance with relevant industry standards such as ISO 13485 and AS 9100.
• Keep comprehensive records of quality-related activities including audits, inspections, and corrective actions.
• Lead preparations and management of internal and external quality audits and certifications.

Qualifications

• Bachelor's degree in Engineering, Quality Management, or a related discipline, or equivalent professional experience.
• At least 5 years’ senior experience in quality roles within manufacturing or engineering sectors.
• Expertise in quality methodologies and tools like root cause analysis, FMEA, and SPC.
• Experience with quality management systems and standards such as ISO 13485 and AS 9100.
• Strong analytical, organisational, and communication capabilities.
• Proficiency with quality software and MS Office applications.

Preferred Qualifications

• Certifications in quality or process improvement fields like CQE, CQA, or Six Sigma Green/Black Belt.
• Knowledge of statistical analysis tools.
• Documented success in driving process improvement initiatives.