Quality Systems Specialist

Published: 6/14/2022

Technology

Job Description

We are seeking an experienced Quality Assurance (QA) Specialist to join our team on a 4–6 month contract to support critical quality and regulatory initiatives. This position has the potential to transition into a full-time role based on performance and business needs.

The ideal candidate will have a strong background in medical device quality systems, FDA regulations, and quality engineering, with the ability to work independently in a fast-paced environment.

Key Responsibilities

Support FDA Quality Management System Regulation (QMSR) remediation activities.
Maintain and improve the company's Quality Management System (QMS).
Manage design changes and change control processes.
Create, review, and update Standard Operating Procedures (SOPs).
Participate in risk management activities in accordance with applicable standards.
Support verification and validation (V&V) activities.
Ensure compliance with quality requirements throughout the medical device manufacturing process.
Collaborate with cross-functional teams to accelerate quality-related projects.
Assist with quality documentation, audits, and continuous improvement initiatives.

Qualifications

Required:

Bachelor's degree in Engineering, Life Sciences, Microbiology, or a related field.
Experience working in the medical device industry.
Strong knowledge of Quality Management Systems (QMS).
Experience with FDA Quality Management System Regulations (QMSR).
Experience with design change/change control processes.
SOP writing and document control experience.
Knowledge of risk management methodologies.
Experience supporting verification and validation activities.
Understanding of medical device manufacturing processes.
Excellent written and verbal communication skills.
Bilingual in English and Spanish.

Employment Details

Job Type: Contract (4–6 months)
Potential for Full-Time Employment: Yes, based on performance and business needs.
Compensation: Competitive; based on experience.