Senior Engineer, Quality System

About the role

Working Location: Pennsylvania, Center Valley
Workplace Flexibility: Hybrid

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. 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.
• Coverage with other functions 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.
• Will act as an expert resource in applicable standards and local QMS requirement knowledge for cross functional teams.
• Compile and support Quality System Management Reviews 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.
• 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.

Job Qualifications

• Minimum of 5 years’ experience in a highly regulated manufacturing environment required.
• Ability to identify issues determine root cause and implement solutions.
• Ensure compliance to standards regulations and Company procedures.
• 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.
• Must be self-motivated with a strong sense of urgency to solve issues and the ability to consistently deliver on required activities.
• Demonstrates the highest ethical standards actively promotes trust respect and integrity in all dealings both inside and outside the Company.

Preferred

• Minimum of 2 years’ experience working in an FDA regulated environment preferred.
• Knowledge of regulatory requirements such as FDA QSRs, ISO 13485, & EU MDR 2017/745 preferred.
• Experience in audit management, front room and back room coordination and best practices preferred.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive medical, dental, vision coverage effective on start date
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance*
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center**

Connected Culture

• Work-life integrated culture that supports an employee centric mindset
• Offers onsite, hybrid and field work environments
• Paid volunteering and charitable donation/match programs
• Employee Resource Groups
• Dedicated Training Resources and Learning & Development Programs
• Paid Educational Assistance

Posting Notes

• United States (US)
• Pennsylvania (US-PA)
• Center Valley
• Quality & Regulatory Affairs (QA/RA)