Duties and Responsibilities:
- The QE will be a principal player in preparing HSI for ISO-9001 certification
- Support creation, maintenance, and improvement of the HSI ISO-9001 Management Quality System
- Originate QMS Documentation, Quality Plans, Incoming Inspection & In process Test Plans.
- Implement and manage quality requirements on Projects/Programs/Products according to contract requirements (i.e. specification, statement of work, PO, HSI best practice, etc.) to ensure compliance and customer satisfaction
- Coordinate/ChairProject/Product non-conformance reporting and MRB (Material Review Board)
- Supplier Quality Management: working alongside the Manufacturing Operations team the QE will support supplier qualification, review and define project flow-down requirements to Suppliers; and work with key suppliers to drive improvement in quality, cost, and schedule
- Represent QA function and associated requirements at product design reviews
- Lead Corrective Action and Continuous Improvement efforts/projects
- Maintain process and product test records
- Participate and support the business on product quality and champion the use of quality tools (e.g. FMEA, QFD, etc.) when needed
- Participate in QMS Continuous Improvement and Management Meetings
- Provide Quality Training for quality awareness, QMS processes, and quality tools
Functional Skills/Knowledge:
- 5 plus years of experience as a Quality Engineer in a R&D and/or Manufacturing environment
- Direct experience with a combination of AS9100, ISO 9001, ISO 13485, ISO 27001 Quality Systems and driving certification.
- Must have Direct hands-on Experience with Government/Military/SBIR contracts & MIL-standards
- Experience with Medical Product Compliance standards such as UL, CE, FCC is a plus
- Knowledgeable in continuous improvement methods and techniques e.g. LEAN, Six Sigma is highly desirable
- ASQ Member and Certification as CQE preferred; CQA desirable
- Proficient in Quality Engineering Tools and Methods
- Self-starter with the ability to lead and motivate teams
- Proficient in MS applications coupled with the use of ERP and PLM systems
- BSEE, BSME, or BSIE
- Experience working in a small growing business environment is a plus
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