Job Title: Quality Engineer - Systems Manager

Job Description

The Quality Systems Manager is a dynamic quality professional with 3-5 years of experience in a regulated industry. This role involves working closely with the Director of Quality and Regulatory Affairs to maintain and enhance the Quality Management System (QMS) through daily quality system activities in a medical device manufacturing environment. The position demands direct engagement in quality processes to ensure compliance with FDA, MDSAP, EU MDR, and other relevant regulatory requirements.

Responsibilities

Actively maintain and improve the Quality Management System in a medical device manufacturing environment.Ensure compliance with regulatory standards including FDA, MDSAP, and EU MDR.Conduct root cause analysis and manage corrective and preventive actions (CAPA).Review and manage non-conformance reports (NCR) and material review boards (MRB).Collaborate with engineers to complete technical documentation.Work across multiple departments to ensure proper and efficient documentation.Conduct internal and external audits to uphold quality standards.

Essential Skills

3-5 years of experience working under ISO13485 standards in a manufacturing environment.Proficiency in managing Quality Management Systems.Experience with RCA, CAPA, NCR, and MRB processes.Ability to work cross-functionally across departments.

Additional Skills & Qualifications

Bachelor's degree highly preferred.Engineering exposure is beneficial.

Work Environment

The role is based in an office setting with working hours from 8 AM to 5 PM. The work environment is collaborative and supportive, offering daily provided lunches and robust benefits. This is an opportunity to contribute to a growing and dynamic organization.

Job Type & Location

This is a Permanent position based out of Middlebury, CT.

Pay and Benefits

The pay range for this position is $90000.00 - $100000.00/yr.

Key benefits reported by employees include health and dental insurance, 403(b) retirement matching, tuition reimbursement, and paid holidays. Insurance: Medical and dental insurance options are available.Retirement: The company offers 403(b) matching.Time Off: Benefits include paid holidays and approximately 6 days of PTO per year.Work Culture: Employees often cite a supportive environment with flexibility in time and location.Career Growth: Opportunities for professional development, such as tuition reimbursement, are offered.

Workplace Type

This is a fully onsite position in Middlebury,CT.

Application Deadline

This position is anticipated to close on Mar 3, 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 actalentaccommodation@actalentservices.com for other accommodation options.