Quality Systems Specialist

Job Description

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.

• 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.

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.

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