Quality Management Systems (QMS) Specialist - Contract

Position Summary

We are recruiting a diligent Quality Management Systems (QMS) Specialist for a 12-month contract position at a medical device company undergoing transition into pharmaceutical operations. The candidate will be a proactive quality expert, capable of independently managing QMS duties and driving initiatives to successful completion.

Key Duties

• Take ownership of QMS tasks, working autonomously while collaborating with relevant stakeholders.
• Oversee Change Control processes to guarantee proper assessment, documentation, implementation, and closure of changes.
• Lead deviation investigations, including coordinating follow-up measures and ensuring timely resolution.
• Manage CAPA procedures by defining, tracking, and implementing corrective and preventive actions effectively.
• Contribute to maintaining and refining the site Quality Management System continuously.
• Work closely with cross-functional teams to ensure quality standards are clearly understood and achieved.
• Offer quality perspectives for projects, process modifications, and operational activities as needed.
• Provide assistance in validation-related tasks, leveraging validation experience to enhance QMS activities.
• Identify potential quality risks proactively and facilitate their resolution without needing close oversight.
• Ensure quality records and documentation are precise, compliant, and well maintained.

Qualifications and Experience

• Demonstrated pharmaceutical Quality Management System experience.
• Hands-on expertise in Change Control, Deviations, and CAPA processes.
• Capable of independently managing QMS functions to completion.
• Excellent problem-solving, investigative capabilities, and stakeholder management skills.
• Experience working within regulated, cross-functional teams.
• Strong verbal and written communication abilities.
• Experience in medical device companies transitioning to pharmaceutical sectors is a plus.
• Validation experience in regulated pharmaceutical or medical device environments highly preferred.
• Familiarity supporting or engaging with validation, qualification, or compliance initiatives.
• Experience across both medical device and pharmaceutical quality systems beneficial.
• Prior involvement in QMS implementation, transition, or improvement projects.