Quality Engineer

Location

Oregon City, OR

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.

• Complete all required training.
• 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 as applicable.
• Collect, analyze, and present data using statistical methodology.
• Assist suppliers with the interpretation of quality requirements as applicable.
• Assist the development of QMS deliverables/Advanced Product Quality Planning (APQP), including complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification and validation.
• Plan and/or conduct process and equipment validations and special validations, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Interface with appropriate customer contacts to clarify customer requirements.
• 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.
• 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 to achieve optimum quality within the limits of equipment capability.
• Review and approve product/process and document change requests.
• Review 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.
• Support measuring and analyzing key metrics to monitor performance.
• Work with cross‑functional teams to solve production and quality problems.
• Reinforce safety expectations and ensure safety operating practices are demonstrated.
• Report issues/concerns to supervisor.
• Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).

• Education – Bachelor’s degree required;
  Bachelor of Science preferred.
• Experience – 3+ years required; 3+ years in a manufacturing environment preferred; experience in medical device manufacturing preferred.
• Licenses & Certifications – Any quality certification preferred.
• Knowledge & Skills – Operational functions, quality management, process management, basic communication, accuracy and attention to detail, manufacturing safety, lean manufacturing, statistical analysis and measurement, PPAP, production runs, final inspection, computer knowledge, problem solving.

• Must be able to remain in a stationary position frequently.
• Must be able to move within the building occasionally.
• Must be able to move equipment around the building occasionally.
• Must be able to position oneself and move under/around/over equipment occasionally.
• Must be able to communicate and exchange information with others frequently.
• Must be able to distinguish and detect information such as writing and defects frequently.
• Noise exposure occasionally.

Noise exposure occasionally.

• Opportunity to work in a growing company.
• Opportunity to help people live longer, more active lives.
• Comprehensive benefit package.
• Integrity, teamwork, and results–oriented culture.

• Candidates may be required to submit to a pre‑employment background check and pre‑employment drug screening.
• Applicants must be authorized to work for any employer in the U.S.; we do not sponsor visas.
• Proof of eligibility to work in the United States through eVerify is required.

At Orchid, we fully support a diverse and inclusive workplace and we are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, hair type, age, status as a protected veteran, or disability.