Quality Engineer, Sustaining Product Quality

Job Summary

A brief overview:
The Quality Engineer I supports the ongoing quality of Orchid's legacy products & processes and works cross‑functionally to sustain the business.

• 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.
• 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.
• 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, 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.
• Interfaces with appropriate customer contacts to clarify customer requirements.
• 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 with minimal assistance.
• Reinforces safety expectations, ensures safety operating practices are demonstrated, and reports issues/concerns to supervisor.
• Supports quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).

• Associates of Science (A.S) (Preferred)
• Bachelor of Science (B.S) (Preferred)

• No previous work experience required (Required)
• 2+ Years of Experience in a Manufacturing Environment (Preferred)
• Experience in Medical Device Manufacturing (Preferred)

• Any Quality Certification (Preferred)

• 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 – Basic Knowledge
• Production Part Approval Process (PPAP) – Basic Knowledge
• Production Runs – Working Experience
• Final Inspection – Basic Knowledge
• Computer Knowledge – Working Experience
• Problem Solving – Working Experience

• Must be able to remain in a stationary position.
• Must be able to move about the inside of the building.
• Must be able to move equipment around the building.
• Must be able to…