Manufacturing Quality Engineer - Compunnel : Job Details

Key Responsibilities:

• Develop and implement effective process control systems for product development, qualification, and manufacturing.
• Lead the deployment of CAPA systems, process controls, and quality assurances that meet/exceed regulatory and customer expectations.
• Serve as a leader or team member in quality-related decisions and activities.
• Apply systematic problem-solving methodologies to resolve quality issues and drive improvements.
• Contribute to the design and execution of streamlined business systems that enhance issue identification and resolution.
• Promote compliance and quality culture across all work functions and ensure adherence to quality standards.

Supplier Quality Engineer Responsibilities:

• Improve supplier performance using Part Quality Plan (PQP) strategies.
• Review, clarify, and approve PQP submissions; ensure on-time execution.
• Conduct supplier audits and manage supplier qualification processes.
• Ensure supplier adherence to QMS and regulatory standards.
• Oversee CAPA plans for assigned suppliers and ensure proper implementation.

Qualifications:

• Bachelor's degree in Engineering or a technical discipline (or non-technical degree with 7+ years of relevant experience).
• 3–5 years of experience in manufacturing, quality assurance, engineering design, or regulatory roles.
• Strong analytical and problem-solving skills, especially in root cause analysis and driving change.

Desired Characteristics:

• ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) preferred.
• Proficiency in Quality Management System (QMS) tools and continuous improvement methodologies.
• Experience in supplier quality within the medical device industry highly preferred.