Biztech Inc
Quality Manager
Full Time • Denville
Job Summary:
The Quality Manager oversees and improves quality systems across manufacturing sites, ensuring compliance with ISO 9001, ISO 13485, and industry standards. This role leads quality initiatives, manages audits, handles nonconformances, and supports team training and development.
The Quality Manager oversees and improves quality systems across manufacturing sites, ensuring compliance with ISO 9001, ISO 13485, and industry standards. This role leads quality initiatives, manages audits, handles nonconformances, and supports team training and development.
Key Responsibilities:
- Ensure compliance with quality standards and regulations
- Lead quality assurance across multiple regions and product lines
- Oversee handling of nonconformances and corrective actions
- Maintain and improve the Quality Management System (QMS)
- Support internal and external audits
- Mentor and train quality staff
- Monitor quality trends and implement improvements
- Collaborate across departments to ensure quality goals are met
- Manage supplier quality and quality agreements
- Support continuous improvement initiatives
- Enforce documentation standards and company policies
Requirements:
- Bachelor’s degree in a related field (Master’s preferred)
- 5+ years of quality management experience, including 3+ in pharma, biotech, or medical devices
- Knowledge of ISO 9001, ISO 13485, Six Sigma
- Strong leadership, communication, and problem-solving skills
- Proficiency in quality tools and software
- Relevant certification (e.g., CQE, CQM) preferred
Compensation: $140,000.00 - $170,000.00 per year
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