Senior Quality Engineer

Combining Strengths. Expanding Possibilities. Tecomet and Orchid are now one company. Explore more at  ABOUT US

Our Oregon City, OR site was established in 1969 and joined Orchid in 2012. The site focuses primarily on investment casting, 3D wax printing, machining, finishing and coating of orthopedic implants for extremities and large joint markets.

Robotic wax assembly, internal tooling and design, finished machining, polishing, and sintered bead coating are our core capabilities. The 80,000‑sq‑ft, FDA‑registered facility employs approximately 175 team members and ships nearly 1 million hip and knee joint implants annually.

We manufacture medical implants from start to finish, fully integrated and compliant with ISO 13485:2016.

ORE – Shift 1 ($0) – United States of America – Oregon

The Senior Quality Engineer supports the ongoing quality of Orchid''s legacy products across all sites. Key responsibilities include managing relationships with critical customers, working with project management and manufacturing engineers on new product introductions and validations, and planning and executing training based on business needs.

• Provide and document training on standard work instructions, policies and procedures in a timely manner to equip team members for independent work.
• Use 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.
• Act as a customer liaison and process customer quality complaints.
• Collect, analyze and present data using statistical methodology.
• Assist suppliers with interpreting quality requirements.
• Assist the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including complaint analysis, risk analysis, FMEA, CAPA and process/equipment/software verification/validation.
• Plan and/or conduct process and equipment validations and special validations including IQ, OQ and PQ.
• Determine machine and/or process capability through Process Capability studies.
• Develop inspection criteria that align customer requirements with manufacturing processes, identifying key characteristics, sampling plans and required gauging.
• Interface with customer contacts to clarify requirements.
• Lead productivity improvement and continuous improvement projects.
• Monitor engineering production processes and products for adherence to internal and external requirements and practices.
• Participate in pre‑ and post‑production launch reviews providing quality engineering support.
• Perform quality reviews and internal audits, evaluate data and write associated reports.
• Recommend modifications to existing quality or production standards to achieve optimum quality within equipment capability limits.
• Review and approve product/process and document change requests.
• Review drawings to evaluate quality requirements, including proper application of GDT, use of process and material specifications, and key characteristics for inspection plans and gauging techniques.
• Support measurement and analysis of key metrics to monitor performance.
• Work with cross‑functional teams to solve production and quality problems.
• Create and manage the overall course structure and set up course programs based on specifications; reinforce safety expectations, ensure safety operating practices are demonstrated, and report issues or concerns to the supervisor.
• Support quality and compliance by adhering to all QMS procedures, work instructions, and forms.

• Bachelor of Science (B.S) – Required
• Master of Science (M.S) – Preferred

• 5+ years of experience – Required
• 5+ years in a manufacturing environment – Preferred
• Experience in medical device manufacturing – Preferred

• Any quality certification – Preferred

• Operational functions – Extensive experience
• Quality management – Extensive experience
• Process management – Working experience
• Communication – Working experience
• Accuracy and attention to detail – Working…