Working Location: California, San Jose

Workplace Flexibility: Onsite

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.