Sr Quality Systems Spec Exempt

North Haven, CT - USA

Monthly Salary: Not Disclosed

Posted on: 22 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Quality Systems Specialist

Client: Medical Device Manufacturing Industry

Duration: 12 Months (Possible Extension)

Location: North Haven CT 06473

Shift: 1st Shift

Top Skills Required

Quality Systems Management (Production & Process Controls Medical Device preferred)
Project leadership / management
QMS document change management

Role Summary

Provides leadership and oversight for Quality Management System (QMS) processes to ensure regulatory compliance and continuous improvement within a regulated medical device environment.

Key Responsibilities

Oversee and maintain quality systems processes and procedures
Interpret and ensure compliance with regulatory and governmental requirements
Lead audit and inspection preparation execution and issue resolution
Partner with operations on ongoing process analysis and compliance enforcement
Manage QMS document changes and quality program updates
Support legal and regulatory requests as needed
Lead or manage projects and cross-functional initiatives
Mentor and guide junior team members

Qualifications

Bachelors degree with 4 years of relevant experience
or Advanced degree with 2 years of experience
Strong experience in regulated industries (Medical Device preferred)
Knowledge of project management practices

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Job Title: Quality Systems Specialist Client: Medical Device Manufacturing Industry Duration: 12 Months (Possible Extension) Location: North Haven CT 06473 Shift: 1st Shift Top Skills Required Quality Systems Management (Production & Process Controls Medical Device preferred) Project leaders...