Quality Systems Specialist – Supplier Quality & Compliance

We are seeking a Quality Systems Specialist to support and maintain our Quality Management System (QMS) with a strong focus on supplier quality regulatory compliance quality documentation and controlled substance processes within a regulated healthcare distribution environment.

This role is responsible for managing supplier and customer quality interactions supporting quality agreements developing and maintaining SOPs and ensuring compliance with applicable regulatory requirements including FDA DEA and ISO 13485 standards.

Note: This is a quality systems and regulatory compliance role within a regulated healthcare environment. It is not an IT/software Quality Assurance software testing or automation testing position.

• Coordinate and complete customer and supplier quality questionnaires.
• Support supplier qualification onboarding and ongoing supplier management activities.
• Maintain supplier quality files and supporting documentation.
• Collaborate with Quality Regulatory Operations Security Legal and Compliance teams to gather required information.
• Ensure questionnaire responses are accurate consistent audit-ready and aligned with current quality system requirements.
• Identify quality or compliance risks and escalate findings appropriately.

• Review and support negotiation of customer and supplier quality agreements.
• Evaluate quality regulatory and compliance requirements within contracts.
• Ensure agreements clearly define responsibilities for quality complaints recalls deviations audits and regulatory compliance.
• Track agreement approvals renewals revisions and periodic reviews.

• Author revise and maintain Standard Operating Procedures (SOPs).
• Support document control processes and training documentation.
• Ensure procedures align with regulatory requirements internal standards and industry best practices.
• Drive continuous improvement and process standardization initiatives.

• Develop and maintain procedures related to receipt storage distribution inventory control reconciliation and returns of controlled substances.
• Support processes involving chain of custody traceability security controls and loss/theft reporting.
• Ensure compliance with applicable DEA regulations and internal security requirements.

• Support quality system activities including document control training compliance supplier management and continuous improvement initiatives.
• Ensure records are maintained according to ALCOA principles and document retention requirements.
• Participate in internal audits supplier audits inspections and compliance assessments as needed.
• Promote risk-based decision-making across quality processes.

• Bachelors degree in Science Healthcare Quality Engineering or a related field or equivalent experience.
• 3 5 years of experience in Quality Systems Supplier Quality Regulatory Compliance or Quality Assurance within a regulated industry.
• Experience working with Quality Management Systems (QMS).
• Knowledge of supplier qualification supplier quality management and quality documentation.
• Strong technical writing and SOP development skills.
• Experience supporting audits inspections or compliance programs.
• Excellent communication organization and cross-functional collaboration skills.

• Experience in pharmaceutical medical device healthcare distribution life sciences or other regulated industries.
• Knowledge of ISO 13485 FDA regulations DEA requirements or Good Distribution Practices (GDP).
• Experience supporting quality agreements and supplier audits.
• Experience with electronic Quality Management Systems (eQMS) such as MasterControl.
• ASQ certification (CQE CQA or equivalent).