Senior Quality Engineer

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

Office located in Oregon City, OR. The site was established in 1969 and joined Orchid in 2012. It focuses on investment casting, 3‑D wax printing, machining, finishing and coating of orthopedic implants for extremities and large joint markets. The 80,000‑square‑foot FDA‑registered facility employs approximately 175 team members and ships nearly 1 million hip and knee joint implants to our customers, helping patients live longer, active lives.

The site is fully integrated and complies with ISO 13485:2016.

Shift: ORE – Shift 1 ($0) – United States, Oregon.

The Senior Quality Engineer supports the ongoing quality of Orchid's legacy products across all sites by fostering strong relationships with critical customers, working with project management and manufacturing engineers on new product introductions and validation, 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 ensure team members have the required knowledge and skills before performing work independently.
• 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 techniques.
• Act as a customer liaison and process customer quality complaints as applicable.
• Collect, analyze, and present data using statistical methodology.
• Assist suppliers with the interpretation of quality requirements as applicable.
• Assist the development of essential QMS deliverables and Advanced Product Quality Planning (APQP), including complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software validation.
• Plan and conduct process and equipment validations and special validations including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Determine machine and/or process capability through planning and/or executing process capability studies.
• Develop inspection criteria that connect customer requirements and manufacturing processes, including identification of key characteristics, associated sampling plans, and required gauging.
• Interface with appropriate customer contacts to clarify customer requirements.
• Conceive and/or lead productivity improvements 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, where applicable, to achieve optimum quality within equipment capability limits.
• Review and approve product/process and document change requests.
• Review drawings to evaluate quality requirements such as proper application of geometric dimensioning and tolerance, proper use of process and material specifications, and key characteristics for inspection plans and gauging techniques.
• Support measuring and analyzing 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/concerns to Supervisor.
• Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).

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

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

• Any quality certification –…