Senior Engineer, Quality Systems

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.

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.

• 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.

• 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…