Senior Quality Engineer

cGxPServe; Watertown (MA); On-site; USD 120,000 - 199,000; Full time

Job summary

A leading company in research services is seeking a Senior Quality Engineer to evaluate and enhance contract manufacturing processes. This role involves ensuring regulatory compliance, optimizing manufacturing efficiencies, and driving continuous improvement in the Quality Management System. The ideal candidate will have extensive experience in manufacturing processes, regulatory standards, and effective project management skills.

Qualifications

• 6-8 years of experience in manufacturing and supplier quality engineering.
• Experience with process validations and contract manufacturer management.
• Strong knowledge of ISO 13485 standards.

Responsibilities

• Evaluate and improve contract manufacturers' processes through research and collaboration.
• Design and implement testing methods to ensure product and process quality.
• Conduct internal and supplier quality audits.

Skills

Communication

Organizational skills

Project management

Analytical skills

Problem-solving

Education

Bachelor's degree in engineering or a related technical field

Tools

Microsoft Office

Job description

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• Evaluate and improve contract manufacturers' processes through research, design, and collaboration.
• Develop and optimize manufacturing processes and equipment in partnership with vendors.
• Onboard and manage contract manufacturers, ensuring regulatory compliance.
• Enhance manufacturing efficiency through workflow and layout analysis.
• Design and implement testing methods to ensure product and process quality.
• Serve as a key resource for manufacturing and quality-related inquiries.
• Ensure compliance with regulatory standards to maintain product reputation.
• Support design and development projects, including training contract manufacturers.
• Maintain quality engineering functions such as supplier controls, audits, and validations.
• Participate in Material Review Board and CAPA processes to address non-conformances.
• Drive continuous improvement of the Quality Management System (QMS).
• Conduct internal and supplier quality audits.
• Create and maintain documentation for product specifications, validations, and design history files.
• Support QMS functions such as document control, training, and device history record management.
  
  

Responsibilities

• Evaluate and improve contract manufacturers' processes through research, design, and collaboration.
• Develop and optimize manufacturing processes and equipment in partnership with vendors.
• Onboard and manage contract manufacturers, ensuring regulatory compliance.
• Enhance manufacturing efficiency through workflow and layout analysis.
• Design and implement testing methods to ensure product and process quality.
• Serve as a key resource for manufacturing and quality-related inquiries.
• Ensure compliance with regulatory standards to maintain product reputation.
• Support design and development projects, including training contract manufacturers.
• Maintain quality engineering functions such as supplier controls, audits, and validations.
• Participate in Material Review Board and CAPA processes to address non-conformances.
• Provide design control support for new product development, including risk management.
• Drive continuous improvement of the Quality Management System (QMS).
• Conduct internal and supplier quality audits.
• Create and maintain documentation for product specifications, validations, and design history files.
• Support QMS functions such as document control, training, and device history record management.
  
  

Requirements

• Bachelor's degree in engineering or a related technical field, or equivalent experience.
• 6-8 years of experience in manufacturing and supplier quality engineering.
• Experience with process validations and contract manufacturer management.
• Background in medical devices and FDA-regulated industries.
• Strong knowledge of ISO 13485 standards.
• Excellent communication, organizational, and project management skills.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Strong analytical and problem-solving abilities with a proactive mindset.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Research Services

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