Job Opening
Quality Manager
Department
QualityLocation
Devens, MAReports To
CEOFLSA Status
Exempt
Summary
The QA Manager will be responsible for planning, directing, and improving the Quality Management System which best utilizes site resources to support the reliability and quality of both custom-designed and standard products and services and meets the demands and expectations of customers in the bio/pharmaceutical markets.
Responsibilities
- Ensures and sustains the compliance of the YMC America QMS system to ISO 9001:2015 and support surveillance audits.
- Maintains quality plans and procedure manuals.
- 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.
- Manages key performance indicators.
- 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.
- Ensures that individuals performing functions affecting quality are appropriately trained and demonstrate the appropriate skills and performance results.
- Leads root cause analysis teams to ensure proper and correct identification of non-compliant issues.
- Reviews quality data to recommend improvements to processes.
- Collaborates with Purchasing to implement Supplier Quality Management process
- Understands and conveys company policies and procedures.
- Responsible for annual quality management system review meetings.
- Actively demonstrates YMC values including honesty, integrity, continuous innovation, and diversity.
Required Experience and Knowledge
- Bachelor 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 understanding 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
Preferred Skill 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
Apply to This Position
Department
Quality
Location
Devens, MA
Reports To
CEO
FLSA Status
Exempt
Summary
The QA Manager will be responsible for planning, directing, and improving the Quality Management System which best utilizes site resources to support the reliability and quality of both custom-designed and standard products and services and meets the demands and expectations of customers in the bio/pharmaceutical markets.
Responsibilities
- Ensures and sustains the compliance of the YMC America QMS system to ISO 9001:2015 and support surveillance audits.
- Maintains quality plans and procedure manuals.
- 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.
- Manages key performance indicators.
- 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.
- Ensures that individuals performing functions affecting quality are appropriately trained and demonstrate the appropriate skills and performance results.
- Leads root cause analysis teams to ensure proper and correct identification of non-compliant issues.
- Reviews quality data to recommend improvements to processes.
- Collaborates with Purchasing to implement Supplier Quality Management process
- Understands and conveys company policies and procedures.
- Responsible for annual quality management system review meetings.
- Actively demonstrates YMC values including honesty, integrity, continuous innovation, and diversity.
Required Experience and Knowledge
- Bachelor 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 understanding 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
Preferred Skill 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
