Orchid Orthopedic Solutions is looking to improve the ongoing quality of their legacy products and processes and sustain the business by hiring a Quality Engineer I.
Requirements
- Operational Functions - Working Experience
- Quality Management - Working Experience
- Process Management - Working Experience
- Accuracy and Attention to Detail - Working Experience
- Manufacturing Safety - Working Experience
- Lean Manufacturing - Working Experience
- Statistical Analysis and Measurement - Basic Knowledge
Responsibilities
- Uses quality tools to suggest and implement improvements including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques.
- Assists the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification / validation
- Plans and/or conducts process and equipment validations and special validations including installation qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Aids in the determination of machine and/or process capability through planning and/or executing Process Capability studies
- Develops inspection criteria that connect customer requirements and manufacturing processes that include identification of key characteristics, associated sampling plans, and required gauging.
- Monitors engineering production processes and products for adherence to internal and external requirements and practices.
- Performs quality reviews and internal audits; evaluates data and writes associated reports
Other
- Provides and documents training on standard of work instructions, policies, and procedures in a timely manner to ensure team members have the required knowledge and skills prior to performing work independently.
- Acts as a customer liaison and processes customer quality complaints, as applicable.
- Assists suppliers with the interpretation of quality requirements, as applicable.
- Interfaces with appropriate customer contacts to clarify customer requirements
- Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
