Quality Systems Manager

Drive Quality & Compliance Excellence – Join PRC Saltillo as a Quality Systems Manager!

At PRC Saltillo, quality and compliance are at the heart of everything we do—and we’re looking for a skilled Quality Systems Manager to help lead the way. In this role, you’ll be responsible for maintaining and strengthening our quality management systems to ensure compliance with regulatory requirements such as ISO, FDA, and other certifying bodies. You’ll partner across departments, lead audits and assessments, manage risk, and support continuous improvement efforts that protect our mission and the people we serve.

If you’re detail driven, collaborative, and passionate about quality systems and regulatory excellence, this is your opportunity to make a meaningful impact within a mission driven organization.

Go to our website to apply https://prentkeromich.bamboohr.com/careers

Why You’ll Love Working Here

Mission Driven Work: Support a culture of quality and compliance that helps improve lives.

Leadership Impact: Play a key role in shaping and maintaining company wide quality systems.

Cross Functional Collaboration: Work closely with teams across the organization to drive continuous improvement.

Continuous Improvement: Lead initiatives that strengthen processes, mitigate risk, and enhance performance.

Duties and Responsibilities

Maintain an efficient, compliant quality management system (QMS) to ensure objectives are met and corrective actions are implemented as needed.

Assign, monitor, and support corrective and preventive actions (CAPAs), observations (OBs), and opportunities for improvement (OFIs).

Develop and deliver monthly CAPA, OFI, and OB reports for the Leadership Team and produce annual performance improvement reports.

Collaborate with departments to develop, maintain, and ensure adherence to required processes and procedures.

Facilitate and support assessments, audits, and inspections conducted by regulatory agencies and certifying bodies.

Serve as the primary contact for QMS software, overseeing implementation, training, support, and ongoing improvements.

Proactively manage organizational risk by implementing systems to prevent failures, reduce recall likelihood, and mitigate compliance risk.

Education and Experience

Bachelor’s degree in a Quality or Compliance related field required.

At least one year of professional experience in regulatory affairs or quality management systems related to medical devices required.

Required Skills/Abilities

Strong analytical and organizational skills with the ability to coordinate multiple activities and delegate effectively.

Thorough knowledge of quality management systems, manufacturing planning, inventory control, and production processes.

Working knowledge of ISO 13485, FDA, ACHC, and European Medical Device Regulation (EUMDR) requirements.

Excellent written, verbal, and interpersonal communication skills.

Self-motivated with the ability to work independently under minimal supervision.

Team oriented mindset with the ability to collaborate across all organizational levels.

Flexibility and adaptability in a fast paced, changing environment.

Proficiency in Windows and Microsoft Office (Word, Excel, PowerPoint) and experience with document control and ERP systems.