Senior Engineer, Quality System

Olympus Corporation; Center Valley (Lehigh County); Hybrid; USD 95,000 - 140,000; Full time

Benefits offered by this job

Competitive salaries, annual bonus and

401(k) with company match

Comprehensive medical, dental, vision

24/7 Employee Assistance Program

Wellbeing Program (live and on-demand)

Paid Vacation and Sick Time

Parental Leave and Adoption Assistance

12 Paid Holidays

On-Site Child Daycare, Café, Fitness

Job summary

Olympus Corporation in Center Valley, PA seeks a Quality Systems professional to develop and maintain the QMS across the Americas, aligning with US and international requirements. You will drive continuous improvement, lead CAPAs, coordinate audits, and collaborate with cross-functional partners to ensure robust quality governance.

The role focuses on procedural harmonization, documentation control, and data-driven improvements, with a strong emphasis on ethics, urgency, and regulatory

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 PC-based applications (Microsoft Word, Outlook, Excel and PowerPoint); Visio skills desirable.
• Demonstrated ability to manage and complete multiple projects and objectives.
• Work precisely according to procedures, rules and regulations; strong urgency to solve issues and deliver activities.
• Demonstrates the highest ethical standards and promotes trust and integrity.

Responsibilities

• Establish, implement, and maintain a robust Quality System across the Americas per US and international requirements.
• Review and approve releases of changes to QMS documentation.
• Coordinate with functions/sites to ensure efficient change processing.
• Standardize quality procedures across the business and ensure consistent implementation.
• Lead CAPAs as process coordinator and owner.
• Support internal and external Quality Audits and ensure corrective actions are completed.
• Act as Audit Finding coordinator and expert on applicable standards for cross-functional teams.
• Support Quality System Management Reviews with site leadership.
• Report performance of the quality system to management for review and improvement.
• Lead quality system projects leveraging project management techniques.
• Develop innovative solutions to complex process problems and system improvements.

Skills

Quality System

CAPA

Audits

Data analysis

Project management

SOP improvements

Regulatory compliance

Microsoft Word

Excel

PowerPoint

Visio

Tools

Microsoft Word

Excel

PowerPoint

Visio

Job description

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.


• 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.

Benefits

Equitable Offerings you can count on

• 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 you can embrace

• 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


• US Only


• Center Valley, PA and Westborough, MA

Applicants Requesting Accommodations

Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Equal Employment Opportunity Statement

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.

Inclusive Workplace

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.