Olympus Corporation of the Americas Quality Systems Engineer II in Littleton, Massachusetts
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.
To develop, maintain and continuously improve the Quality System across the Americas by driving industry best practices, procedural harmonization and seamless quality system integration. 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.
Ensures that a Quality System is established and implemented and maintained to the highest levels of accordance with US and International requirements.
Review and approve release of changes to QMS documentation. Coordinate with other functions (Engineering Supply Chain Quality etc.) and sites to ensure accurate complete and efficient change processing.
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.
Lead CAPAs as process coordinator – execute on CAPAs when assigned as CAPA owner.
Support and participate internal and external Quality Audits (including notified bodies and health authorities) and ensure related corrective action activities are completed in a robust and timely manner. Act as Audit Finding coordinator.
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.
Compile and support Quality System Management Reviews and monthly Quality Progress Meeting with site leadership.
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 · All Other Essential Duties as assigned by Management
Bachelor's degree or equivalent in an engineering or life science discipline.
Minimum of 3 years progressively responsible experience operating as a Quality Engineer in a highly regulated manufacturing environment required. Minimum of 1 year working in an FDA regulated environment preferred.
Ability to identify issues determine root cause and implement solutions.
Ensure compliance to standards regulations and Company procedures.
Knowledge of regulatory requirements such as FDA QSRs, ISO 13485, & EU MDR 2017/745 preferred.
Identify and facilitate process and SOP improvements within the Quality System embracing a culture of continuous improvement.
High level of proficiency in most common PC based applications (Microsoft Word, Outlook, Excel and PowerPoint required - Visio skills desirable).
Demonstrated ability to manage and complete multiple projects and objectives.
Works precisely according to procedures rules and regulations has a passion for continuous improvement and quality.
Demonstrates the highest ethical standards actively promotes trust respect and integrity in all dealings both inside and outside the Company.
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 requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.
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) || Littleton ||
Olympus Corporation of the Americas
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