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Quality System Engineer, Principal
2 months ago
We are seeking a highly skilled Quality System Engineer, Principal to join our team at Olympus Corporation of the Americas. As a key member of our Quality and Regulatory Affairs department, you will be responsible for developing, maintaining, and continuously improving the Quality System across the Americas.
Key Responsibilities- Develop and implement industry best practices, procedural harmonization, and seamless quality system integration.
- Act as an ambassador of global quality harmonization, sharing, developing, deploying, and integrating strategic plans and practices across Olympus globally.
- Interface with functional business partners to ensure the development and implementation of the quality system meets business needs and enables innovation and flexibility in the business.
- Ensure the Quality System is established, implemented, and maintained to the highest levels of accordance with US and international requirements.
- Review and approve release of changes to QMS documentation and assess impact to QMS certification, addressing any substantial changes with the Notified Body.
- Manage Notified Body communication and relationship.
- Support and participate in internal and external Quality Audits, including health authorities and notified bodies, and ensure related corrective action activities are completed in a robust and timely manner.
- Support the CAPA process.
- Provide resident expertise in the application of Quality sciences, including data analysis, problem-solving, and the creation of system solutions for Quality System issues.
- Act as an expert resource in applicable standards and local QMS requirement knowledge for cross-functional teams.
- Lead/support 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 improvements through the use of best practices.
- BS degree or equivalent in an engineering or life science discipline. Master's Degree preferred.
- Minimum of 8 years' experience working in a highly regulated industry required.
- Demonstrated ability to manage and complete multiple projects and objectives and lead projects with cross-functional teams.
- Proficient with Risk Management practices and Regulatory Requirements such as FDA, QSRs, ISO 13485.
- Experience in audit management, front room and back-room coordination, and best practices.
- Will work with global teams, availability will include working across the associated time zones.
- Preferred: Minimum of 3 years' experience working in an FDA-regulated environment preferred. Six Sigma Black Belt preferred. Knowledge of emerging regulatory standards and changes to global regulatory landscape preferred.
Olympus Corporation of the Americas offers a competitive salary, annual bonus, and 401(k) with company match. We also provide comprehensive medical, dental, and vision coverage, as well as a 24/7 Employee Assistance Program. Our company culture values work-life balance, diversity, and inclusion, and we offer a range of benefits to support our employees' well-being and career growth.
