Quality Systems Specialist

QRC Group; Cidra (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

QRC Group in Cidra, Puerto Rico seeks a Quality Systems Specialist to support documentation accuracy, regulatory compliance, and the implementation and maintenance of quality system requirements. You will work with cross-functional teams to ensure SOPs and processes meet industry standards and regulatory expectations.

Responsibilities include drafting and maintaining quality documentation, supporting audit readiness, and assisting in CAPA, change control, and deviation management activities.

Qualifications

• Bachelor's degree in Science, Engineering, or a related technical discipline.
• 2–3 years of experience in a regulated medical device, pharmaceutical, biotechnology, or life sciences environment.
• Experience writing, revising, and maintaining controlled procedures and quality system documentation.
• Experience supporting Quality Management Systems (QMS).
• Familiarity with Change Control and Deviation Management processes.

Responsibilities

• Support execution of QMS activities and corrective action plans.
• Assist in ensuring Quality System processes comply with regulatory requirements and company policies.
• Draft, review, revise, and maintain controlled quality documentation (SOPs, Work Instructions, Forms, Templates).
• Support remediation tracking and provide status updates to Quality Management.
• Participate in continuous improvement initiatives to enhance processes and maintain compliance.
• Assist during audits (Internal, Supplier, Customer, FDA, Notified Body, MDSAP).
• Maintain audit readiness through documentation and follow-up of findings.
• Support Change Requests, Complaint Monitoring, and Deviation Management.

Skills

Organizational skills

Attention to detail

Written communication

Verbal communication

Regulatory compliance

QMS experience

Change control

Deviation management

Education

Bachelor's degree in Science/Engineering or related technical discipline

Job description

Cidra, Puerto Rico | Posted on 08/28/2026

We are seeking a Quality Systems Specialistwill collaborate with cross-functional teams to support documentation accuracy, regulatory compliance, and the implementation and maintenance of quality system requirements.

Responsibilities

• Support the execution of QMS activities and corrective action plans.
• Assist in ensuring Quality System processes comply with applicable regulatory requirements, company policies, and industry standards.
• Draft, review, revise, and maintain controlled quality documentation, including SOPs, Work Instructions, Forms, and Templates.
• Support track remediation activities and provide status updates to Quality Management.
• Participate in continuous improvement initiatives by identifying opportunities to enhance processes and maintain compliance.
• Support the harmonization of procedures and implementation of quality best practices across departments.
• Assist during Internal, Supplier, Customer, FDA, Notified Body, and MDSAP audits.
• Help maintain audit readiness through accurate documentation and timely follow-up of audit observations and findings.
• Support Change Requests (CRs), Complaint Monitoring, and Deviation Management activities as needed.
• Perform other quality-related duties as assigned.

Requirements

• Bachelor's degree in Science, Engineering, or a related technical discipline.
• 2-3 years of experience in a regulated medical device, pharmaceutical, biotechnology, or life sciences environment.
• Experience writing, revising, and maintaining controlled procedures and quality system documentation.
• Experience supporting Quality Management Systems (QMS).
• Familiarity with Change Control and Deviation Management processes.
• Strong organizational skills and attention to detail.
• Effective written and verbal communication skills.