Senior Quality Core Team Lead - Remote (Japan-Based)

Olympus America, Inc.; Pennsylvania; Remote; USD 140,000 - 190,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

401(k) match

Paid vacation

Parental leave

On-site daycare

Job summary

Olympus America, Inc. seeks a Senior Manager for Quality Core Team to lead quality strategy across cross-functional NPD projects. The role focuses on planning quality/reliability strategies, DRM metrics, and acting as the final quality authority on project teams.

The position requires extensive QA/QSR experience in medical devices, with travel up to 10% and a base in a remote work setting; ideal for a leader who can drive DFSS, risk management, and robust design controls across a global program.

Qualifications

• Bachelor of Science in engineering or scientific discipline required; Design/Process Green Belt is a plus.
• Minimum of 8 years of experience in a drug/device manufacturer with focus on QSR compliance and quality assurance.
• Minimum of 5 years’ experience supporting NPD with 3+ years as a Quality Core Team member.
• Knowledge of basic mechanical, electrical, software, optical, or biological engineering.
• Working knowledge of FDA QSRs, MDSAP, ISO 13485, Design Controls, and Risk Management practices.

Responsibilities

• Represent voice of quality on cross-functional NPD project teams.
• Provide oversight for multiple project areas within the Quality domain on NPD projects.
• Drive quality improvements, risk management, and CAPA across product development.

Skills

Quality management

NPD quality

QSR compliance

Risk management

FMEA

Cross-functional leadership

Project management

Statistical methods

Design Controls

Communication skills

Education

B.S. in engineering or science

Design or Process Green Belt

Tools

Quality tools suite

Metrology & Calibration

Statistical software

Job description

Olympus America, Inc. seeks a Senior Manager for Quality Core Team to lead quality strategy across cross-functional NPD projects. The role focuses on planning quality/reliability strategies, DRM metrics, and acting as the final quality authority on project teams.

The position requires extensive QA/QSR experience in medical devices, with travel up to 10% and a base in a remote work setting; ideal for a leader who can drive DFSS, risk management, and robust design controls across a global program.