Olympus CorporationRemote
Principal Quality Engineer
United States of America
Full Time
1 week ago
$104,000 - $146,000 USD
No H1B
Key skills
Quality System ManagementRisk ManagementFDA Regulatory RequirementsQSRsISO 13485Audit ManagementCAPA ProcessSix Sigma Black BeltPC Applications - WordPC Applications - ExcelPC Applications - PowerPointPC Applications - ProjectPC Applications - VisioProject ManagementLeadershipCommunicationProblem Solving
About this role
Olympus Corporation is a global medical technology company focused on advancing medical technologies and improving patient care. The Principal Quality Engineer will develop and maintain the Quality System across the Americas, ensuring compliance with industry standards and driving quality initiatives across the organization.
Responsibilities:
- Ensure that a Quality System is established, implemented, and maintained to the highest levels of accordance with US and lnternation requirements
- Review and approve release of changes to QMS documentation and assess impact to QMS certification, addressing any substantial changes with the Notified Body
- Ensure lntercompany Quality Agreements are established and maintained
- Manage Notified Body communication and relationship
- Support and participate in internal and external Quality Audits (including health authorities and notified bodies) an ensure related corrective action activities are completed in a robust and timely manner
- Support the CAPA process
- Show strong ability to influence without direct authority across functional groups, regions and leadership
- Provides resident expertise in the application of Quality sciences including data analysis, problem solving and the creation of system solution for Quality System issues
- Will 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 solution to complex and unique process problems and system improvement through the use of best practices
- All Other Essential Duties as directed
Requirements:
- BS degree or equivalent in an engineering or life science discipline
- 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 crossfunctional 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
- Must be self-motivated with a strong sense of urgency to solve issues and the ability to consistently deliver on required activities
- Strong track record of leading and influencing without direct authority
- Excellent interpersonal, communication (written and oral), presentation and facilitation skills
- Proficient in most common PC based applications (work, excel, PowerPoint, Project, & Visio)
- Demonstrate the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company
- Will work with global teams, availability will include working across the associated time zones
- Master's Degree 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