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. Brief Overview 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. What You Will Do 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). Education Qualifications Bachelor of Science (B.S.) – Required Master of Science (M.S.) – Preferred Experience Qualifications 5+ years of experience – Required 5+ years of experience in a manufacturing environment – Preferred Experience in medical device manufacturing – Preferred Licenses and Certifications Any quality certification – Preferred Knowledge & Skills That Enable Success 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 processing – Working experience Lean assessment – Extensive experience Problem solving – Working experience What We Offer Opportunity to work in a growing company Ability to help people live a longer, more active life Comprehensive benefit package Work in an organization that values: Integrity First: We do the right thing Teamwork: We are one Orchid Results: Our results matter Additional Requirements Candidates offered employment may be required to submit to a pre‑employment background check and pre‑employment drug screening based on position requirements. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. Candidates must be able to provide proof of eligibility to work in the United States through eVerify. 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 race, color, religion, sex, sexual orientation, gender identity, national origin, hair type, age, status as a protected veteran, or disability. Orchid Orthopedic Solutions only pays fees for solicited presentations of job seekers submitted through its preferred vendor job board by recruiters, employment agencies, or other parties. #J-18808-Ljbffr Stryker Corporation