Overview
We are seeking a Quality Manager to join our team. This individual will be responsible for maintaining and overseeing our ISO 9001 : 2015 and ISO 13485 : 2016 certifications, ensuring that our processes, documentation, and products consistently meet the highest standards of quality and compliance. The Quality Manager will also play a key role in representing Diamond Tool Manufacturing with customers and stakeholders.
Key Responsibilities
- Maintain and manage ISO 9001 : 2015 and ISO 13485 : 2016 certification requirements.
- Oversee and coordinate internal and external audits.
- Manage and resolve customer complaints in a timely and professional manner.
- Serve as the primary quality representative with customers, ensuring effective communication and relationship management.
- Oversee ERP system usage and ensure quality-related data is maintained accurately.
- Develop, review and update quality documentation, procedures and records.
- Collaborate with production and engineering teams to resolve quality issues.
- Analyze quality data and prepare detailed reports for management.
- Conduct root cause analysis and implement corrective and preventive actions (CAPA).
- Ensure compliance with medical device regulatory requirements and industry standards.
- Provide training and support to employees in quality procedures and standards.
- Monitor supplier performance and support supplier quality management activities.
- Foster a culture of continuous improvement within the organization.
Qualifications
Proven knowledge and hands-on experience with ISO 9001 : 2015 and ISO 13485 : 2016.Experience with ERP systems.Strong background in internal audits and handling customer complaints.Experience with corrective and preventive actions (CAPA).Strong organizational and documentation skills.Proficiency in MS Office (Word, Excel, PowerPoint) and database management.Excellent report-writing, communication and problem-solving skills.Ability to lead cross-functional teams and interact with all levels of the organization.Previous experience in a manufacturing or medical device environment.Bachelor\'s degree in Quality, Engineering or related field; relevant certifications (e.g. Six Sigma, ASQ) a plus.About the Company
Diamond Tool Manufacturing is an ISO 9001 : 2015 and ISO 13485 : 2016 certified manufacturer of industrial and medical grade cutting devices. A company dedicated to producing quality products for our customers.
J-18808-Ljbffr