Growing contract manufacturer for single use, disposable medical devices is looking for a dependable individual to join our team. The Quality Engineer should be a self-driven team player who has strong organizational and communication skills. This position reports to the Quality Assurance Manager.
- Monitoring and improvement of product quality.
- Defect, scrap and rework prevention.
- Continuous improvement of and adherence to Quality Management System.
- Control, document, evaluate and disposition nonconforming materials.
- Coordinate and monitor inspection activities
- Investigate, document and communicate customer complaints. Notify QM if event is reportable per Medical Device Vigilance Reporting standards and requirements
- Supplier Quality evaluation, monitoring, and improvement.
- Review and approve validation activities.
- Support Design and Design Transfer activities as needed.
- Sterilizations for both ETO and Gamma Radiation in accordance with the appropriate standards.
- Ensure adequacy and compliance of Environmentally Controlled Areas.
- Provide support for and perform Document Control activities as needed.
- Coordinate and perform Corrective Action and Preventive Action activities as required.
- Internal auditing as required.
- Provide guidance on regulatory requirements.
- Perform and/or prepare installation, operational, and performance qualification of equipment as needed.
- Provide product specifications and task specific instructions for use by Assembly and Quality, personnel and when required specifying the type of inspection or measuring equipment to be utilized.
- Conduct investigations for equipment failing calibration.
- Complete, review and approve fixture files as necessary
- Assist in maintaining traceability of products.
- All other duties as assigned.
Required Skills, Knowledge and Expertise
- Working knowledge of ISO13485, ISO 9001, FDA CFR Part 820, Medical Device Directives
- Medical Device Directives and product – specific applicable standards
- FDA Quality System Regulations
- Canadian Medical Device Regulations
- EtO sterilization
- Gamma Sterilization
- Quality Management Tools
- Problem Solving
- Root Cause Analysis
- Supplier Performance
- Project Management
- Advanced Product Quality Planning (APQP)
- Proficient in Microsoft Office Software suite
- Scientific education (biological sciences or other technical)/Quality Certifications (ASQ or other)/Quality/Regulatory experience in medical device manufacturing
Competitive benefits offered; however, Phase 2 Medical does not offer relocation packages.
Unsolicited, Non-Contracted Agencies not subject to “finder’s fee”.