Senior Quality Manager — Medical Devices & CAPA

Velocity medtech; Totowa (NJ); On-site; USD 110,000 - 130,000; Full time

Job summary

Velocity medtech in Totowa, NJ seeks a Quality Assurance/Quality Control leader to manage and optimize all facets of the company’s quality system in a fast-paced medical device environment.

The role requires expert knowledge of QSR, ISO 9001, ISO 13485, CAPA, and change control, with hands-on leadership and cross‑functional collaboration across engineering, manufacturing, and regulatory teams.

Qualifications

• Bachelor’s degree in Engineering or a relevant scientific discipline with 7+ years of experience (Master’s with 5+ years acceptable).
• Expert understanding of QSR, ISO 9001, ISO 13485, control plans and ISO 14971 required.
• Experience with GLP, sterilization equipment/methods, and engineering principles in real-world settings.

Responsibilities

• Manage and monitor performance of all quality assurance and quality control aspects.
• Implement, manage and develop the company’s quality system.
• Lead CAPA, document control, change control, internal and external audits.
• Support supplier development and controls, process validation, and QC statistics.
• Mentor team members and interact with senior management across departments.

Skills

Quality management

QSR ISO 9001

ISO 13485

ISO 14971

CapA management

Leadership

Audit

Documentation control

Education

Bachelor’s degree in Engineering or related

7+ years in medical device QC/QA

Master’s degree favored

Certifications (CQE/CQA/LQ Auditor)

Six Sigma Green Belt desirable

Tools

Gage R&R

Statistical methods

GD&T

Job description

Velocity medtech in Totowa, NJ seeks a Quality Assurance/Quality Control leader to manage and optimize all facets of the company’s quality system in a fast-paced medical device environment.

The role requires expert knowledge of QSR, ISO 9001, ISO 13485, CAPA, and change control, with hands-on leadership and cross‑functional collaboration across engineering, manufacturing, and regulatory teams.