Principal Supplier Quality Engineer

Website Olympus Corporation of the Americas

In order to be considered, applicants must apply at our website:

Job Description
The Principal Supplier Quality Engineer is responsible for supporting cross-functional project teams focused on proactive improvement initiatives with OSTA suppliers and external manufacturers for legacy products and support of new products under development. The incumbent proactively collaborates with external manufacturers and suppliers that provide finished products, services, components, and sub-assemblies to continuously improve supplier-based products and processes that meet customer and patient requirements.

Job Duties
* Lead cross-functional supplier risk management initiatives proactively focused on supplier development and driving continuous improvement activities across OSTA suppliers.
* Utilize effective and efficient Quality Engineering and Process Excellence tools and techniques such as CtQ Cascades, root cause analysis, risk analysis, statistical data analysis, process capability analysis, design of experiments, measurement system analysis, control plans, and development of sampling plans to aid in supplier development.
* Develop the strategy and execute a proactive, risk-based Supplier Management Process that includes development and trending of Supplier Metrics – such as NC’s / SCAR’s Audit Results.
* Collaborate with cross-functional teams and suppliers to design, characterize, develop and qualify high capability processes that continuously improve products and processes that consistently fulfill OSTA requirements and meet customer needs.
* Collaborate and approve supplier sourced component and subassembly specifications and/or drawings.
* Support the Supplier Management Program by performing technical process audits, and managing Supplier SCAR’s and SCN’s.
* Lead and provide feedback on performance, and train other employees, including exempts and contractors.
* Willingness to travel up to approximately 30 – 50%. (US & some international)
* Perform other duties as assigned.


Job Requirements

* Bachelor’s degree or equivalent in an engineering or life science discipline and a minimum of 10 years of experience working in manufacturing, finished medical device or related industry with manufacturing processes, operational excellence, quality system and continuous improvement activities OR the overall equivalent in related years of experience.



* MBA or other advanced degree preferred
* Knowledge of Risk Management practices, Corrective and Preventative Actions, Process Validation and regulatory requirements such as FDA QSR’s, ISO 13485, & ISO 14971 are required.
* Six Sigma Green Belt and Lean certifications, Six Sigma Black Belt is preferred.
* Proficiency with DMAIC / Black Belt / Six Sigma type tools to analyze, drive root cause, and solve problems.
* Proficiency with statistics, sampling strategies, design of experiments, process capability, including statistical software tools such as Minitab.
* Possess Lead Auditor credentials for QSR, ISO and MD SAP.
* Must be self-motivated with a strong sense of urgency to solve supplier issues and the ability to consistently deliver on required activities.
* Demonstrated ability to manage and complete multiple projects and objectives and lead cross-functional teams.
* Excellent interpersonal, communication, presentation and facilitation skills.
* Proficient in most common PC based applications (Word, Excel, PowerPoint, Project, & Visio), including Agile PLM.


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