Lead Quality Assurance Specialist
2 days ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Aurolab. This role is responsible for ensuring the company's products meet all quality standards.
The successful candidate will have a strong background in quality assurance and be proficient in implementing and maintaining an ISO 13485-compliant Quality Management System.
You will work closely with cross-functional teams to ensure documentation readiness for certifications and audits. Additionally, you will be responsible for developing, reviewing, and approving documents according to quality terms.
In this role, you will also interact with external audit teams and conduct audits peacefully. You will assist in MDR documentation and CE certification readiness from a quality perspective.
Key Responsibilities:
- Capture and improve in-process yield metrics.
- Implement non-conforming material processes and resolve rework, scrap, or return to vendor.
- Understand parts, processes, and performance.
- Streamline incoming parts quality and track metrics.
You will be involved in new organizational initiatives and 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.
We offer a competitive salary range of $80,000 - $120,000 per year, depending on experience.
Qualifications:
- Bachelor's degree in a scientific, engineering, or related field. Advanced degree preferred.
- 8-12 years of experience in Quality Assurance in relevant industries.
- Thorough knowledge of regulatory guidelines (e.g., FDA, EMA, ISO standards).
- Strong organizational skills, attention to detail, and 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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