Careers at Masis Staffing Solutions

Are you looking to join an up and coming company in the medical device industry? Look no further!

We are seeking a Quality Manager who will support the implementation, maintenance, and continuous improvement of our Quality Management System (QMS), ensuring compliance with all applicable FDA and ISO standards.

Position Summary

The Quality Manager is responsible for overseeing all aspects of Clients QMS and serves as the Representative for quality. This role ensures compliance with U.S. FDA regulations (21 CFR Parts 820, 801, 803, 11) and ISO 13485 standards, driving a culture of quality and continuous improvement across the organization.

The successful candidate will work closely with R&D, Manufacturing, Regulatory, and Supplier Quality teams to maintain high product and process standards and to prepare the organization for audits and regulatory submissions.

Key Responsibilities:

• Maintain, and continually improve Clients Quality Management System (QMS) in compliance with FDA and ISO 13485 requirements.
• Serve as the Representative for all QMS activities.
• Monitor and report the effectiveness of the QMS to the team through regular metrics and reviews.
• Manage CAPA, complaint handling, nonconformance, and feedback systems to ensure timely resolution and trend analysis.
• Ensure quality system procedures, documentation, and records remain current and compliant.
• Collaborate with internal teams and suppliers to improve product quality and manufacturing practices.
• Support internal and external audits, including, ISO 13485 audits, and supplier audits.
• Partner with the Supplier and technical consultants to ensure supplier compliance and quality performance.
• Identify quality improvement opportunities and lead controlled implementation of corrective actions.
• Provide quality training and support across departments to reinforce compliance awareness and ownership.
• Represent the Quality function in project meetings, regulatory reviews, and management discussions.
• Perform other duties as assigned by management.

Qualifications

• Bachelor’s degree in engineering, Life Sciences, or related technical discipline (Master’s preferred).
• 5+ years of experience in Quality Management within an FDA-regulated medical device environment (IVD experience strongly preferred).
• Demonstrated experience with ISO 13485 and 21 CFR Part 820 Quality System Regulation.
• Experience with electronic QMS platforms (e.g., MasterControl, CompliantPro) preferred.
• Some experience with FDA and ISO 13485 audits is preferred.
• Strong understanding of design control, risk management, and document control processes.
• Excellent written and verbal communication, analytical, and problem-solving skills.
• Ability to lead and influence cross-functional teams while maintaining strong attention to detail.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint).
• Willingness to travel domestically and internationally as needed.

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