What are the responsibilities and job description for the Quality Manager position at TriMech Services?
Quality Manager
Quality Manager Responsibilities:
Quality Manager Required Experience & Knowledge:
Quality Manager Preferred Skills and Experience
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Quality Manager Responsibilities:
- Ensures and sustains the compliance of Client’s QMS system to ISO 9001:2015 and support surveillance audits.
- Provides management oversight of the QC Supervisor to ensure proper processes, instructions, inspection methods and test plans are in place and adequately support the customer requirements.
- Writes and reviews internal operating procedures.
- Effectively manages the site corrective and preventative action system and processes.
- Analyzes quality data and metrics to ensure process health is adequate to accomplish planned and future work and process flows are followed.
- Assists in the development, establishment, and enforcement of quality assurance measures and standards.
- Leads the site internal audits and surveillances process to measure and assure adherence to the QMS standards and overall quality goals.
- Leads external customer audits and coordinates follow up to actions resulting from such audits.
- Leads root cause analysis teams to ensure proper and correct identification of non-compliant issues.
- Collaborates with Purchasing to implement Supplier Quality Management process.
Quality Manager Required Experience & Knowledge:
- Bachelor’s degree in a technical / engineering or other appropriate field in combination with electro-mechanical comprehension and comprehensive knowledge of manufacturing processes is required.
- 4 years of related experience in progressive roles with manufacturing companies, preferably providing products within the biopharmaceutical, pharmaceutical, med-device or related industries.
- Regulatory experience in ISO-9001:2015, 21 Code of Federal Regulations (CFR) Part 11 and a general understand of GAMP 5 Software Validation requirements.
- Effective presentation skills to communicate to all levels on issues that include Quality Plans and Quality Management Systems, performance metrics and improvement systems.
- Proficiency in Microsoft Office including Excel, Word, and PowerPoint
Quality Manager Preferred Skills and Experience
- Experience with manufacturing of metal fabrication items and clean welding fabrications a plus.
- Certification by the American Society for Quality (ASQ) as a Certified Quality Engineer (CQE) or Certified Quality Manager (CQMgr) preferred.
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