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Quality Manager

Quality Manager

ZipRecruiterPlymouth, MA, US
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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

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