Quality Engineer
Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
We are seeking a Quality Engineer with experience in the medical device industry to support quality assurance regulatory compliance and continuous improvement initiatives. The ideal candidate will have a strong background in FDA regulations ISO 13485 risk management (ISO 14971) and product lifecycle management including design control and CAPA systems.
Responsibilities:
- Ensure compliance with FDA 21 CFR Part 820 ISO 13485 and other applicable regulatory standards.
- Support design control activities including design verification/validation risk analysis (FMEA FTA) and product release.
- Develop and maintain quality documentation including SOPs work instructions inspection plans and validation protocols.
- Perform root cause investigations and drive Corrective and Preventive Actions (CAPA) to resolution.
- Conduct or support internal audits supplier audits and regulatory inspections.
- Monitor and improve product quality metrics (yield complaints non-conformances etc.).
- Collaborate with cross-functional teams (R&D Manufacturing Regulatory Supply Chain) to ensure quality is built into processes and products.
- Lead or assist in supplier quality management activities including qualifications audits and performance monitoring.
- Participate in risk management processes and ensure appropriate risk controls are implemented.
- Support changing control processes for product or process changes.
- Contribute to continuous improvement initiatives using tools such as Six Sigma Lean and 8D.
- Bachelors degree in engineering Life Sciences or related field.
- 2 5 years of quality engineering experience in the medical device or regulated industry.
- Strong knowledge of FDA QSR (21 CFR Part 820) and ISO 13485.
- Experience with risk management (ISO 14971) and design control practices.
- Hands-on experience with CAPA Company validations (IQ/OQ/PQ) and audits.
- Proficient in quality tools such as FMEA 8D Root Cause Analysis etc.
- Excellent analytical documentation and communication skills.
Employment Type
Full-time
