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Principal Quality Engineer

Req ID:  657

Working Location: CALIFORNIA, SAN JOSE; FLORIDA, MIAMI; MASSACHUSETTS, SOUTHBOROUGH; MINNESOTA, BROOKLYN PARK; PENNSYLVANIA, CENTER VALLEY 

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

To develop, maintain and continuously improve the Quality System across the Americas by driving industry best practices, procedural harmonization and seamless quality system integration through development of robust ICQAs and Quality plans. Act as an ambassador of global Quality harmonization to share, develop, deploy and integrate strategic plans and practices across Olympus globally. To interface with functional business partners within the quality system to ensure that development and implementation of the quality system meets business needs as well as enables innovation and flexibility in the business.

Job Duties

In a typical day, you will:

 

* Ensures that a Quality System is established and implemented and maintained to the highest levels of accordance with US and International requirements.

 

* This responsibility includes acting as a liaison with all global regions within Olympus to drive harmonization and establishment of models of excellence within the Olympus medical space to drive global adoption of these practices.

 

* Ensures robust incorporation of all OGBRs into regional practices.


* Interaction with external parties on matters relating to the organization’s Quality System and its continued development in accordance with changes in Regulatory Agency requirements and Business needs.


* Ensures that the quality procedures are standardized throughout the business and ensures that they are implemented consistently and correctly.

 

* Identifies areas of focus through data driven trending and brings solutions to management. This responsibility includes liaising with internal and external parties on matters relating to the organization’s Quality System and its continued development in accordance with changes in Regulatory Agency requirements and Business needs.


* Ability to synthesize quality signals, extract critical information to inform plans and develop actions for addressing and improving the quality system.


* Shows strong ability to influence without direct authority across functional groups, regions and leadership

 

* Provides resident expertise in the application of Quality Sciences including, statistics, data analysis, problem solving and the creation of system solutions for Quality System issues.

 

* Report on the performance of the quality system to Company management, as directed, for review and as a basis for improvement of the quality systems

 

* Perform all other duties as directed.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's Degree in Engineering required.

 

* Minimum of 6 years’ experience working in manufacturing, finished medical device or related regulated industry with manufacturing processes, operational excellence, quality systems, and continuous improvement activities required.

 

* Six Sigma Black Belt preferred. Proficient with DMAIC / Black Belt / Six Sigma type tools to analyze, drive root cause, and solve problems.

 

* Proficient with statistics, sampling strategies, quality systems trending, process capability, including statistical software tools such as Minitab.

 

* Knowledge of Risk Management practices, Corrective and Preventative Actions, Process Validation and regulatory requirements such as FDA QSRs, ISO 13485, & ISO 14971 are required.

 

PREFERRED QUALIFICATIONS:

 

* Master’s Degree preferred.

 

* Knowledge of emerging regulatory standards and changes to global regulatory landscape preferred

 

* Experience in audit management, Front room and back room coordination and best practices preferred

 

* Possess Lead Auditor credentials for QSR, ISO and MD SAP preferred

 

* Must be self-motivated with a strong sense of urgency to solve 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.

 

* Strong track record of leading and influencing without direct authority across functional groups, leadership levels and regions globally.

 

* Excellent interpersonal, communication (written and oral), 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) || Southborough || 

 

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