Senior Quality Engineer

Company: Olympus Corporation of the Americas
Location: Redmond
Posted on: April 8, 2021

Job Description:

Are you looking for a company that cares about people's lives and health, including yours? At Olympus, we help make people's lives healthier, safer and more fulfilling, every day.--
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Let's inspire healthier lives, together. Job Description The Senior Supplier Quality Engineer is responsible for providing support with a focus on supplier quality management activities. Works with external manufacturers and suppliers providing finished products, services, components, and sub-assemblies to ensure compliance with company policies, procedures, and medical device regulations. The Senior Supplier Quality Engineer will partner with Manufacturing Engineering, Operations, R&D, Supply Chain and other departments to continuously improve products and processes that meet customer and patient requirements. Job Duties * Lead supplier quality management for legacy products and support of new products under development per OSTA new product development (NPD) process.
-- * Lead component inspection plans, first article inspection reports (FAIR's), and issue resolution (collaborate with Design Assurance or Quality Engineering, if design or process impacted).
-- * Lead corrective & preventive actions (CAPA's), supplier corrective action requests (SCAR's), and supplier notifications only (SNO's) to resolution, including monitoring, analyzing, and reporting on supplier performance data and metrics.
-- * Lead the evaluation of new or transferred suppliers and/or changes to the Approved Supplier List (ASL).
-- * Lead post-launch supplier sourcing sustainment.
-- * Notify and present high impact to business SCN's to Local Review Boards via Product Release Process (PRP).
-- * Support supplier process management, i.e., risk management, quality assurance agreements, control plans, supplier assessments / audits (QS status), submitted validations (IQ, OQ, PQ, PPQ), process failure modes and effects analysis (pFMEA), and supplier inspection plan / method evaluations.
-- * Collaborate and approve supplier sourced component and subassembly specifications and/or drawings.
-- * Utilize effective and efficient Quality Engineering techniques such as risk analysis, statistical--data analysis, process capability analysis, design of experiments, measurement system analysis, control plans, and development of sampling plans throughout the product lifecycle.
-- * Author, collaborates and approve quality system documentation via Agile PLM.
-- * Perform other duties as assigned by management. Job Requirements REQUIRED QUALIFICATIONS: * Bachelor's Degree in Engineering required. Experience can be substituted for education requirements. * Minimum 5 years of experience in process quality engineering in Medical Device Industry. * Prefer experience with an emphasis on Supplier Quality Management within an FDA-regulated medical device manufacturing environment. * Proficient with DMAIC / Black Belt / Six Sigma type tools to analyze, drive root cause, and solve problems.Proficient with statistics, sampling strategies, design of experiments, process capability, including statistical software tools such as Minitab. * Strong written and oral communication skills are required. PREFERRED QUALIFICATIONS: * Master's Degree preferred. * Proficient with process trouble shooting of parts utilizing injection and insert molding, extrusion, stamping, wire EDM, and CNC machining. * Understanding of the design, development, and tolerancing of complex systems. * Knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR's, ISO 13485, & ISO 14971 are required. * Ability to lead, champion change, and execute strategies to meet goals. * Must be self-motivated with a strong sense of urgency and ability to deliver on required activities. * Must have a sense of ownership and a desire to follow a project from inception to full production. * Proficient in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio), including Agile PLM.-- * ISO 13485 Lead Auditor certification is preferred. * ASQ Certification (CQE & CBA) is preferred. We realize work isn't just a job to you.

It's a big part of your life, but not the only part. That's why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks - so you can be ready for where life can take you. Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world. Olympus' Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus' Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com . It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: -- United States (US) -- Washington (US-WA) -- Redmond ----

Keywords: Olympus Corporation of the Americas, Redmond , Senior Quality Engineer, Engineering , Redmond, Washington