Job Description
Who We Are:Integrated Medical Systems, Inc. (IMS), founded in 1994, is one of the nation's top distributors within the alternate site market. We strive to continually exceed expectations by cultivating valued partnerships and delivering on our commitment to always put our customers first. We offer flexible rental and purchase options for a vast line of disposable and rental products specific to infusion, respiratory, enteral feeding, oncology, and cleanroom.
People at IMS are innovative, dedicated, and experienced to enhance our customer’s experience from start to finish. By joining us, not only will you be working alongside industry experts and thought leaders, but also with a company recognized for its dedication to employee growth and well-being.
What We’re Looking For:
The Quality Manager is responsible for developing, implementing, maintaining, and continuously improving the IMS Quality Management System (QMS). This role ensures compliance with ISO 13485:2016, applicable regulatory requirements, and OEM quality agreements, while supporting IMS’s strategic growth and service expansion. The Quality Manager will serve as the primary owner of quality processes, audits, recall management, and risk management activities across the organization.
Job Requirements
What You Bring to the Table:Required Skills:Bachelor’s degree in Engineering, Life Sciences, Quality, or a related field (or equivalent experience).
5+ years of experience in Quality Management within the medical device industry.
Demonstrated experience managing and maintaining an ISO 13485:2016 compliant Quality Management System.
Strong knowledge of audits, CAPA management, risk management (FMEA), training documentation, and document control.
Experience managing OEM quality agreements and external quality partnerships.
Excellent communication, organizational, and leadership skills.
Preferred Skills:Experience supporting or managing 510(k) submissions.
Working knowledge of ISO 9001.
Experience in service, repair, or post-market medical device environments.
Prior experience building or scaling a Quality function or department.
Strong attention to detail and regulatory rigor
Ability to balance compliance with operational efficiency
Proactive problem-solving and risk-based thinking
Collaborative leadership and cross-functional communication
Job Responsibilities
How You’ll Make an Impact:Quality Management System (QMS):
Own and maintain the IMS Quality Management System in compliance with ISO 13485:2016 and applicable updates.
Ensure QMS processes are effectively implemented, documented, and continuously improved.
Develop and maintain quality policies, procedures, and work instructions.
Regulatory & Compliance:
Lead internal and external audits (ISO, OEM, customer, and regulatory audits).
Manage corrective and preventive action (CAPA) processes, including root cause analysis and effectiveness verification.
Oversee risk management activities, including FMEAs and risk mitigation strategies.
Ensure compliance with applicable regulatory and quality standards.
OEM & Partner Quality:
Manage and maintain OEM quality agreements, ensuring ongoing compliance with partner requirements.
Act as the primary quality liaison with OEMs and external partners.
Support onboarding of new OEM service lines from a quality and compliance perspective.
Recall & Field Action Management:
Lead recall and field action management activities, including investigation, documentation, communication, and closure.
Coordinate cross-functional teams to ensure timely and compliant execution of recalls and safety actions.
Training & Documentation:
Oversee quality-related training programs and training documentation.
Ensure personnel competency and compliance with QMS and regulatory requirements.
Maintain document control systems, including change management and record retention.
Continuous Improvement:
Analyze quality data, trends, and metrics to drive continuous improvement initiatives.
Support process optimization while maintaining regulatory compliance.
Partner with Operations, Biomed, Sales, and Leadership to embed quality into daily operations.
