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Job Title: Quality Engineer

Job Description

The Quality Engineer will assist in the management and implementation of the Quality Management System to ensure compliance with ISO standards and the FDA's Quality System Regulations. This includes responsibilities such as CAPA, complaint handling, internal audits, and product release and distribution.

Responsibilities

+ Lead the effective development, implementation, and continuous improvement of the organization's quality assurance policies, ensuring compliance with medical device standards (ISO).

+ Analyze quality data and metrics to identify trends and areas for improvement.

+ Create and maintain documentation related to quality processes, policies, reference procedures, and work instructions in compliance with ISO and the FDA's Quality System Regulations.

+ Support internal, customer, and regulatory audits as required.

+ Train internal staff on quality procedures and best practices.

+ Support eQMS implementation projects for CAPA, document, and record control.

+ Provide additional support for Quality Management System activities as assigned.

Essential Skills

+ CMM Programming experience or OGP Vision System experience.

+ Working knowledge of ISO, FDA 21 CFR Part 11/820, and ISO in medical device manufacturing.

+ Proficiency in quality tools and methodologies.

+ Knowledge of statistics in the context of medical device development and production.

+ Excellent verbal and written communication skills, both technical and non-technical.

+ Problem-solving and analytical thinking skills to resolve challenges.

+ Ability to function well in a high-paced and sometimes stressful environment.

Additional Skills & Qualifications

+ Bachelor's degree in engineering, quality assurance, or a related field.

+ 5+ years of experience in quality assurance, preferably in the medical device industry.

Work Environment

The role is based in a manufacturing environment requiring appropriate eye protection. There is exposure to high noise levels, necessitating hearing protection. Gowning and sanitation are required for manufacturing in a clean room, as applicable. The position involves prolonged periods of sitting at a desk and working on a computer.

Job Type & Location

This is a Permanent position based out of Rochester, NY.

Pay and Benefits

The pay range for this position is $75000.00 - $95000.00/yr.

Standard Health, Dental, 401k, Retirement, Vision, etc.

Workplace Type

This is a fully onsite position in Rochester,NY.

Application Deadline

This position is anticipated to close on Jan 26, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.