Senior Engineer, Quality Systems

Req ID: 10784

Working Location: California, San Jose

Workplace Flexibility: Onsite

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. 

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus: https://www.olympusamerica.com/careers.

Job Description

The Quality Systems Engineer will be responsible for the continued development and maintenance of the Quality Assurance systems to ensure compliance with the requirements of 21 CFR Part 820 Quality Management System Regulation (QMSR/QSR), ISO 13485, and other quality standards. This individual contributor role will lead Quality Management System (QMS) compliance initiatives, policy implementation, risk assessments, remediation actions, audit readiness, and cross-functional quality system projects. In addition, this individual contributor will provide technical support to align functions, sites, regions, and business units.

Job Duties

Assist with routine and periodic internal and external audits to ensure QMSR / ISO compliance is maintained at all levels of the organization.
Review internal audit responses to ensure they are consistent with policy. Support all departments on the successful execution of the internal audit schedule and policy. Provides quality system support during internal audits, external audits and inspections.
Support Document and Change Control processes and systems including the ongoing maintenance and improvement of database reports and ancillary systems.
Support CAPA and Audit processes and systems including the ongoing maintenance and improvement of database reports and ancillary systems.
Serve as the CAPA Coordinator, backup CAPA Lead, and CAPA mentor for CAPA Owners.
Support in defining implementation approach, deliverables, governance, risks, success criteria, and escalation pathways.
Provides review of QMS changes, procedures, training plans, records, dashboards, and implementation evidence. Provides support and review of Quality Management Reviews (QMRs).
Support and take lead (as needed) of cross-functional meetings, align stakeholders, remove barriers, and drive action closure.
Drive process standardization, compliance technology adoption, digital workflow improvements, and continuous improvement (or 6-sigma kaizen projects). Maintain and improve QMS processes, procedures, and systems to ensure continued compliance with documented requirements and standards.
Support continuous improvement projects related to the development, maintenance, and improvement of Olympus quality management systems. Support quality system data collection and provide regular reports to management on quality system topics such as Audit status, CAPAs, Deviations, Nonconformances, Validations, and Change Controls.
Develop curriculum to provide training and support for established quality systems.
Perform other duties as required.

Job Qualifications

Required:

Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Compliance, or related discipline.
Training in medical device QMS requirements, validations (hardware and software), quality planning, audit support, risk management, project leadership, remediation management, and Good Documentation Practices required.
Minimum of 5 years of experience in Quality Systems, Quality Engineering, Compliance, Regulatory, Engineering, Operations, or a related field.
Working knowledge of medical device QMS requirements and regulated change implementation.
Experience leading quality plans, QMS remediation, policy implementation, regulatory inspection readiness, process standardization, compliance technology implementation (validations).
Experience mentoring cross-functional team members on quality concepts and preparing compliance updates to management.
Strong technical writing, risk-based thinking, stakeholder management, executive communication, and project leadership skills.
Ability to coach and influence cross-functional teams without direct authority.
Ability to translate regulatory and procedural requirements into practical implementation plans.
In office work environment.
Frequent cross-functional engagement across sites and process ownership teams.
Work may include time-sensitive deliverables, audit readiness support, inspection response, remediation tracking, and leadership reporting.
Requires the ability to manage multiple priorities and support business needs across time zones.

Preferred:

Certifications such as ASQ CQA, CQE, CMQ/OE, RAC, Lean Six Sigma, or PMP 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 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

Are you ready to be a part of our team?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position in this location is $104,622.00 - $141,240.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

You Belong at Olympus

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.

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 OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

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.

Posting Notes: || United States (US) || California (US-CA) || San Jose || Quality & Regulatory Affairs (QA/RA)

Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto
Job Segment: Senior Quality Engineer, Quality Engineer, Medical Device Engineer, QA, Quality Assurance, Engineering, Quality, Technology

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