Quality Engineer
Orchid
Summary
The Quality Engineer II supports the ongoing quality of Orchid's legacy products and works with project management and manufacturing engineers to support new production introduction and ongoing validation.
Job description
A Brief Overview
The Quality Engineer II supports the ongoing quality of Orchid's legacy products and works with project management and manufacturing engineers to support new production introduction and ongoing validation.
What You Will Do
- Completes all required training.
- Uses quality tools to 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.
- Acts as a customer liaison and processes customer quality complaints, as applicable.
- Collects, analyzes, and presents data using statistical methodology.
- Assists suppliers with the interpretation of quality requirements, as applicable.
- Assists the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including 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).
- Interfaces with appropriate customer contacts to clarify customer requirements.
- Determines 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.
- Conceives and/or leads productivity improvements and/or continuous improvement projects.
- Monitors engineering production processes and products for adherence to internal and external requirements and practices.
- Participates in pre- and post-production launch reviews providing quality engineering support.
- Performs quality reviews and internal audits; evaluates data and writes associated reports.
- Recommends modifications to existing quality or production standards, where applicable, to achieve optimum quality within limits of equipment capability.
- Reviews and approves product/process and document change requests.
- Reviews drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerance, proper use of process and material specifications, and key characteristics for inspection plans and gauging techniques.
- Supports measuring and analyzing key metrics to monitor performance.
- Works with cross-functional teams to solve production and quality problems.
- Reinforces safety expectations and ensures safety operating practices are demonstrated.
- Supports quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).
Education Qualifications
- Bachelor (Required)
- Bachelor of Science (B.S) (Preferred)
Experience Qualifications
- 3+ Years of Experience (Required)
- 3+ Years of Experience in a Manufacturing Environment (Preferred)
- Experience in Medical Device Manufacturing (Preferred)
Licenses and Certifications
- Any Quality Certification (Preferred)
Knowledge & Skills That Enable Success
- Operational Functions - Working Experience
- Quality Management - Working Experience
- Process Management - Working Experience
- Communication - Basic Knowledge
- Accuracy and Attention to Detail - Working Experience
- Manufacturing Safety - Working Experience
- Lean Manufacturing - Working Experience
- Statistical Analysis and Measurement - Working Experience
- Production Part Approval Process (PPAP) - Working Experience
- Production Runs - Extensive Experience
- Final Inspection - Working Experience
- Computer Knowledge - Working Experience
- Problem Solving - Working Experience
Requirements
- Bachelor's degree (Required)
- Bachelor of Science (B.S.) (Preferred)
- 3+ years of experience (Required)
- 3+ years of experience in a manufacturing environment (Preferred)
- Experience in medical device manufacturing (Preferred)
- Any quality certification (Preferred)
- Quality management working experience
- Process management working experience
- Statistical analysis and measurement working experience
- Lean manufacturing working experience
- Production Part Approval Process (PPAP) working experience
- Problem solving working experience
- Must be authorized to work for any employer in the U.S.; unable to sponsor employment visas
Benefits
- Performance Bonuses
- Insurance
- 401(k) Matching
- Paid Time Off
Company overview
Orchid is a leading medical device company specializing in orthopedic implant manufacturing and contract manufacturing services. The company focuses on developing and producing high-quality orthopedic implants, instruments, and surgical solutions for joint reconstruction, trauma, and spine applications. With advanced manufacturing capabilities and expertise in materials science, Orchid provides comprehensive solutions to orthopedic device manufacturers worldwide. The company operates state-of-the-art facilities with capabilities in machining, forging, casting, and surface treatments for medical-grade metals and polymers. Orchid's commitment to quality and innovation has established it as a trusted partner in the orthopedic industry, serving both large multinational corporations and emerging medical device companies. Their expertise spans the entire product lifecycle from design and development through manufacturing and post-market support.