Senior Quality Systems Lead - QMS, Arena, FDA Medical Devices

Synchron; New York (NY); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Subsidized medical and dental insurance

Life insurance

401k

Unlimited PTO

Flexible Spending Account

Commuter benefits for NY employees

Job summary

A leading medical device company in New York is seeking an experienced Senior Quality Systems Specialist. The role involves managing Document Control processes, administering the Arena eQMS, and driving quality system development. Ideal candidates will have over 5 years of experience in FDA regulated industries and a strong knowledge of medical device regulations. This position offers a salary range of $120,000 to $160,000 along with comprehensive benefits and a culture focused on quality and collaboration.

Qualifications

• 5+ years of experience in an FDA regulated environment.
• Knowledge of medical device Quality Management Systems and applicable regulations.
• Experience with electronic Quality/Document Management Systems (preferably Arena).

Responsibilities

• Own Document Control process and educate personnel.
• Administer Arena eQMS and manage configurations.
• Drive development of Synchron SOPs adhering to compliance standards.
• Conduct audits and support Quality Management Reviews.

Skills

Detail-oriented

Process-driven

Excellent time management

Effective communication

Proactive

Education

Bachelor's degree

Tools

Arena eQMS

Microsoft suite (Word, Excel, Teams, PowerPoint)

Adobe

Job description

A leading medical device company in New York is seeking an experienced Senior Quality Systems Specialist. The role involves managing Document Control processes, administering the Arena eQMS, and driving quality system development. Ideal candidates will have over 5 years of experience in FDA regulated industries and a strong knowledge of medical device regulations. This position offers a salary range of $120,000 to $160,000 along with comprehensive benefits and a culture focused on quality and collaboration.