The Quality Engineer is responsible for Quality Assurance activities ranging from product development through transfer to manufacturing. This is a hands-on role where the Quality Engineer will apply diversified knowledge of engineering, software verification, supplier management and quality principles and practices for implantable medical devices and accessories. This position will report to Director, Quality.
- 6+ years of Quality/Regulatory experience in a medical device or other regulated industry
- Bachelor’s degree in a technical or science major
- Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
- Responsible for execution of quality assurance and quality systems application within the department and across departments
- Project leader on various projects by representing Quality Assurance
- Develop inspection and sampling plans
- Work with outside testing laboratories and representatives from other departments
- Perform/Lead Supplier Audits per audit and business requirements
- Support with Supplier Management and transfer to manufacturing
- Perform failure analysis by collaborating with Engineering on investigation as needed
- Perform data collection and analysis to monitor test results trends
- Perform, coordinate, review, approve, and/or provide guidance on:
- Product Verification & Validation activities
- Product specification
- Computer System Validation
- DHFs, DMRs, DHRs
- Usability Study
- Risk Management
- External Standards
- Corrective action mitigation
- Perform other duties as required
Skills and Knowledge
- 3 years auditing experience in an FDA regulated Class 2 or 3 medical device environment to QSR 21 CFR Part 820 and ISO 13485 quality systems.
- Practical application of statistical concepts including SPC techniques, hypothesis testing, DOE, and sampling plans
- Demonstrated knowledge of QSR (21 CFR 820) / ISO Quality System (ISO 13485), FDA Software guidance of Verification & Validation
- Active Implantable Medical Device Directives (90/385/EEC)
- Understand and working knowledge of IEC 60601-1, IEC 62304, EN ISO 14971, IEC 62366-1, 62366-2, EN 556-1, EN ISO 11135, EN ISO 10993, ASTM D4169, FDA Software Guidance or similar standards, Soldering Standards (IPC-A-610)
- Design Control process
- Highly developed written and oral communication skills and be able to work in a team environment
- Must have good problem solving skills and be able to work independently
- Working knowledge of Corrective Action & Prevention methodology for nonconformity mitigation
- Must be organized, detail-oriented and adaptable according to evolving situations at hand.