Senior Engineer, Quality System

Olympus Corporation of the Americas; Center Valley (Lehigh County); On-site; USD 90,000 - 130,000; Full time

Job summary

Olympus Corporation of the Americas seeks a Quality Systems professional to establish, implement, and maintain a comprehensive Quality System compliant with US and international requirements. You will review changes to QMS docs, coordinate cross-function changes, and ensure standardized procedures are followed across the business.

You will lead CAPAs, support audits, and act as an expert on applicable standards. Strong emphasis on continuous improvement and data-driven quality initiatives.

Qualifications

• Identify issues, determine root cause and implement solutions.
• Improve processes and SOPs within the Quality System.
• Proficiency in common PC apps (Word, Outlook, Excel, PowerPoint); Visio desirable.

Responsibilities

• Establish, implement, and maintain a Quality System compliant with US and international requirements.
• Review and approve changes to QMS documentation.
• Coordinate with functions/sites to ensure efficient change processing.
• Standardize quality procedures across the business and ensure proper implementation.
• Lead CAPAs as process coordinator and execute as CAPA owner when assigned.
• Support internal and external Quality Audits and corrective actions.
• Act as Audit Finding coordinator and expert on applicable standards.
• Support Quality System Management Reviews with site leadership.

Skills

Root cause analysis

Process improvement

Quality Management System

MS Office proficiency

Project management

Visio

Tools

Visio

Job description

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 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.
• All Other Essential Duties as assigned by Management.

Job Qualifications

Required:

• 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.
• All other Essential Duties as assigned by Management.

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.

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.