What are the responsibilities and job description for the Quality Manager position at Commtech Services Inc?
Quality Manager
Overview:
Seeking an experienced Quality Manager to lead and continuously improve site-wide quality systems within a regulated manufacturing environment (pharma, biopharma, or medical device). This role oversees audits, CAPAs, compliance, training, and process improvement, ensuring alignment with ISO 9001, ISO 13485, and other applicable standards.
Key Responsibilities:
Manage and improve plant quality systems and compliance programs.
Lead internal/external audits and oversee corrective/preventive actions.
Maintain and enforce quality policies and ISO certification standards.
Ensure documentation and processes meet regulatory and industry requirements.
Support Quality Agreements and supplier quality audits.
Provide leadership, mentorship, and performance management for QA team.
Analyze trends, identify risks, and implement improvements across departments.
Drive cross-functional collaboration to enhance product and process quality.
Monitor KPIs, cost-efficiency, and department goals.
Ensure team compliance with safety and quality procedures.
Requirements:
Bachelor’s degree in Engineering, Quality, or related field (Master’s preferred).
5 years in a quality leadership role; 3 years in pharma, biopharma, or med device.
Proficient in ISO 9001, ISO 13485, Six Sigma methodologies.
Strong leadership, auditing, and problem-solving skills.
Certified in quality (CQE, CQM) preferred.
Effective communicator with experience managing teams and driving change.
Skilled in quality systems, documentation, and data-driven decision-making.
