Share this Job
Apply now »

Senior Quality Systems Engineer - Global

Req ID:  3147

Working Location: MASSACHUSETTS, WESTBOROUGH; CALIFORNIA, SAN JOSE; COLORADO, GOLDEN; FLORIDA, MIAMI; MASSACHUSETTS, LITTLETON; MASSACHUSETTS, WALTHAM; MEXICO, MEXICO CITY; MINNESOTA, BROOKLYN PARK; MISSOURI, ST. LOUIS; ONTARIO, RICHMOND HILL; PENNSYLVANIA, CENTER VALLEY; QUEBEC, QUEBEC CITY; TENNESSEE, BARTLETT; WASHINGTON, REDMOND 

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

Senior Quality System Engineer will develop, maintain and improve the Olympus Global Quality Management System (GQMS) to ensure it is compliant with all relevant international standards and business requirements. Actively drive the progress of Transform QARA to implement a GQMS. Implement industry best practices, procedural harmonization and seamless quality system integration through development of robust processes 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 users of the system to ensure the GQMS meets the business needs. Serve as Audit and CAPA coordinator as needed to ensure timely execution to QMS activities in these systems. Provides site expertise in the application of Quality Sciences including statistics data analysis problem solving and the creation of system solutions.

Job Duties

* Ensures that a GQMS is established and implemented in accordance with all relevant International requirements and must report on the performance of the quality system to the Company’s management as directed for review and as a basis for improvement of the quality system.

 

* Develop and actively participate in the implementation of global QMS process as part of Transform QARA (TQARA) as directed by the TQARA Project Manager and/or the VP for QMS Global.

 

* Provided global coordination of Audit, CAPA and other QMS processes as directed by the VP of QMS Global. Monitor and communicate status of global KPI metrics for Audit, CAPA and other QMS processes to global management.

 

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

 

* Support and facilitate Internal and External Quality audit activity.

 

* Provide guidance on change management of GQMS and aid in the development of applicable training requirements.

 

* Support key Quality System and organizational initiatives and improvement activities (i.e. Transform QARA and other related Transform Olympus priorities).

 

* All Other Essential Duties as directed.

Job Requirements

REQUIRED QUALIFICATIONS

* Bachelors degree or equivalent and 5+ years related experience and or training; or the equivalent combination of education and experience.

 

* Minimum of 5 years experience in medical device industry with strong quality systems background is essential.

 

* Candidate must have the ability to read write and communicate effectively in English is required; this requirement includes clear understandable speech and demonstrated comprehension skills.

 

* Other Considerations (travel/hours availability, etc.):Up to 40% domestic and international travel. Must be available to work remotely outside of “normal” local business hours to work with teams globally.

 

PREFERRED QUALIFICATIONS

* A strong expert understanding of a quality system and its components is required.


* Good analytical and organizational skills are required.


* Strong understanding and practical application of U.S. FDA QSR, EU MDR, Japanese PMD requirements as well as ISO13485, ISO14971, and other international QMS regulatory requirements.


* Strong attention to detail and accuracy are required.


* Experience training and/or mentoring others is required.


* Excellent verbal and written communication skills.


* Ability to create and deliver training to all levels within the organization.


* Strong people skills ability to effectively interact at all levels within the corporation.

 

* The ability to collaborate and work in a cross-functional environment.


* Must be able to demonstrate a working proficiency in operating a personal computer and to perform basic word processing/spreadsheet tasks using Microsoft Excel and Word applications.


* Fundamental understanding of problem-solving investigation and quality system verification techniques.

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, Manufacturing Engineer, Engineer, Senior Quality Engineer, Engineering, Quality

Apply now »