Senior Engineer, Quality Systems

Olympus Corporation; San Jose (CA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Competitive salaries and annual bonus

401(k) with company match

Comprehensive medical, dental, vision

Paid time off and holidays

On-site amenities: daycare, cafe, gym

Job summary

Olympus Corporation in California, San Jose, is seeking a Quality Systems Engineer to advance the QMS program and ensure readiness for audits and inspections. The role focuses on policy implementation, risk assessment, and cross-functional quality initiatives within a GMP/QMS framework.

You will lead CAPA activities, support document control, drive process standardization, and mentor teams on quality concepts. Onsite work with cross-site collaboration is expected.

Qualifications

• 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.
• 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.
• 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.

Responsibilities

• 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.

Skills

Technical writing

Risk-based thinking

Stakeholder management

Executive communication

Project leadership

Cross-functional coaching

Education

Bachelor’s degree in Engineering/Life Sciences/Quality/Regulatory Affairs/Compliance

Tools

Document control systems

Job description

Overview

Workplace Flexibility: Onsite. Working Location: California, San Jose.
Olympus has focused for more than 100 years on making people’s lives healthier, safer and more fulfilling. This role is part of our Quality Assurance team.

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 role 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.
• 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.

Benefits

• 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.

EEO Statement

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 environment where everyone feels a sense of belonging. Olympus extends equal employment and advancement opportunity to all applicants and employees without regard to any characteristic protected by applicable law.

Accommodations

Applicants requesting accommodations: Olympus is committed to the full inclusion of all qualified individuals. If reasonable accommodation is needed, please contact [e-mail] or call our HR Compliance Manager at 1-888-659-6787.