Director, Quality Systems Job Details | Olympus Corporation of the Americas

Olympus

Optoelectronic Equipment

Westborough, MA - USA

Manager / Team Leader

Experteer Overview

In this role you will oversee the Quality Management System across the Americas, ensuring governance and regulatory alignment. You will lead a regional QMS team, drive sub-system improvements, and deploy global policies to support business objectives. The role focuses on strengthening compliance, enhancing efficiency, and shaping how quality is managed across sites. You will work with cross‑functional partners to advance Olympus’ commitment to patient safety and high standards of care.

Compensation / Benefits

Competitive salaries
annual bonus
401(k) with company match
Comprehensive medical/dental/vision coverage
Paid holidays and vacation
Parental Leave and Adoption Assistance

Responsibilities

Lead and direct the Quality System team in the Americas
Manage staff development and performance; build talent across locations
Prioritize resources to meet strategic objectives and establish department goals
Develop and implement processes supporting the QMS vision for the region
Drive global policies and strategies for Quality Systems and ensure regulatory alignment
Champion QMS sub-systems process improvements and change programs
Oversee QMS governance, including Management Review and CAPA ownership
Ensure QMS KPIs are executed and competency is developed across employees
Support QARA pillars and align resources with QARA objectives
Act as QMS Subject Matter Expert during audits and regulatory reviews
Identify opportunities to improve Olympus compliance profile and efficiency
Perform other duties as assigned

Key requirements

Bachelor of Science
Minimum 10 years of regulated quality experience
Minimum 7 years’ experience managing people across multiple locations/sites/countries
Minimum 7 years in Quality Systems, Document Control and Training
Minimum 7 years in quality/regulatory project management
Strong analytical toolkit
Ability to influence across levels and locations; CQE and/or Six Sigma knowledge beneficial
Proven leadership, integrity, and conflict resolution
Strong decision-making under partial information; organizational agility
Thorough knowledge of 21 CFR 820 and ISO 13485; familiarity with international medical device quality systems