Senior Quality Engineer

Location

United States of America – Oregon

Senior Quality Engineer supports the ongoing quality of Orchid's legacy products across all sites by focusing on strong relationships with critical customers, working with project management and manufacturing engineers to support new product introductions and ongoing validation, and planning and executing training based on business needs.

• Provide and document training on standard work instructions, policies, and procedures to ensure team members have the required knowledge and skills.
• Use quality tools such as process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques to implement improvements.
• Act as a customer liaison and process customer quality complaints.
• Collect, analyze, and present data using statistical methodology.
• Assist suppliers with interpretation of quality requirements.
• Assist in the development of essential QMS deliverables and Advanced Product Quality Planning (APQP) activities, including complaint analysis, risk analysis, failure mode and effects analysis, corrective and preventive action, and process/equipment/software verification and 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 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 customer contacts to clarify requirements.
• Conceive and 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 to provide quality engineering support.
• Perform quality reviews and internal audits, evaluate data, and write 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, ensuring correct application of geometric dimensioning and tolerances, proper 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 and ensure safe operating practices are demonstrated.
• Report issues or concerns to the 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 – Preferred

• Operational Functions – Extensive Experience
• Quality Management – Extensive Experience
• Process Management – Working Experience
• Communication – Working Experience
• Accuracy and Attention to Detail – Working Experience
• Manufacturing Safety – Extensive 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
• Customer Communication – Working Experience
• QSR and ISO – Extensive Experience
• Coaching – Working Experience
• Information…