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.

Requirements

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.
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.

Benefits

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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

quality management systemsregulatory affairscorrective and preventive actionsanalytical skillsmanufacturing planninginventory controlproduction processesISO 13485FDAEuropean Medical Device Regulation

Soft Skills

organizational skillscommunication skillsself-motivatedteam orientedflexibilityadaptabilityability to coordinate activitiesdelegation skillscollaborationindependence