Principal Engineer, Quality Systems Job at Olympus Corporation of the Americas
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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
- 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 and sites to ensure accurate, complete and efficient change processing.
Ensures implementation and execution of Global corporate procedures into regional practices.
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.
Ability to synthesize quality signals, extract critical information to inform plans and develop actions for addressing and improving the quality system.
Support 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, and act as Audit Finding coordinator.
Lead CAPA process, monitoring progress of records, facilitate CAPA board meeting and support CAPA owners to drive closure of corrective actions plans.
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.
Will act as an expert resource in applicable standards and local QMS requirement knowledge for cross functional teams.
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.
Leads/supports significant Quality System projects effectively using a working knowledge of project management techniques.
Develop innovative and practical solutions to complex and unique process problems and system improvement through the use of best practices.
All Other Essential Duties as directed.
Job Requirements
REQUIRED QUALIFICATIONS:
BS degree or equivalent in an engineering or life science discipline. Master’s Degree preferred.
Minimum of 6 years’ experience working in a highly regulated industry required.
Minimum of 3 years’ experience working in an FDA regulated environment preferred.
PREFFERED QUALIFICATIONS:
Demonstrated ability to manage and complete multiple projects and objectives and lead cross-functional teams.
Six Sigma Black Belt preferred. Proficient with DMAIC / Lean Six Sigma /Black Belt type tools to analyse, drive root cause, and solve problems, statistics, sampling strategies, quality systems trending, process capability, with Risk Management practices, Corrective and Preventative Actions, Process Validation and regulatory requirements such as FDA QSRs, ISO 13485, & ISO 14971.
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
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).
Demonstrates the highest ethical standards actively promotes trust respect and integrity in all dealings both inside and outside the Company.
All Other Essential Duties as assigned by Management.
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) || Westborough ||
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