Rochester, New hampshire
Quality Engineer Job Opening in Rochester, New hampshire - 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.
Responsibilities:
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 Expertise2
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
Statistics
Quality Management Tools
Problem Solving
Root Cause Analysis
Supplier Performance
Project Management
Advanced Product Quality Planning (APQP)
Proficient in Microsoft Office Software suite
Desirable Qualifications:
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?.
Job Type: Full-time
Required experience:
Quality Engineer: 2 years
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