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Medical Device Principal Supplier Quality Engineer

Req ID:  1614

Working Location: MASSACHUSETTS, WESTBOROUGH 

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. 
 
Let’s inspire healthier lives, together.

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

REQUIRED QUALIFICATIONS:

 

* 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.

 

PREFERRED QUALIFICATIONS:


* 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.

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.

Olympus…True To You. True To Society. True To LIFE.

 

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) || Massachusetts (US-MA) || Westborough || 


Nearest Major Market: Worcester

Job Segment: Quality Engineer, Engineer, Manufacturing Engineer, ERP, Engineering, Quality, Technology

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