Quality Manager Equipment
4 days ago
Key Responsibilities:
Quality Assurance:
- Capture & improve in-process yield metrics- Final goods performance yield tracking & sustenance- Implement non-conforming material process & resolve rework, scrap or return to vendor- Understand parts, processes and performance- Implement engineering change management- Lead internal and external audits, addressing non-conformities and ensuring timely resolution with CAPA process- Streamline incoming parts quality & track metrics.- Boundary less involvement in new organizational initiatives.- Utilize tools like root cause analysis, Six Sigma, and lean methodologies.- Maintain accurate records of quality processes, inspections, and audits.- Generate regular reports on quality metrics and performance for senior management.
Qualifications:
- Bachelor’s degree in a scientific, engineering, or related field. Advanced degree preferred.- 8-12 years of experience in Quality Assurance in (relevant industry, e.g., pharmaceuticals, medical devices).- Thorough knowledge of relevant regulatory guidelines (e.g., FDA, EMA, ISO standards).- Strong organizational skills, with attention to detail and the ability to manage multiple projects simultaneously.- Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams.
Preferred Skills:
- Certification in Quality Assurance.- Experience with electronic quality management systems (eQMS).- Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
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