INACTIVE JOB POSTING CG2-16: QMS Software Implementation Consultant (PSC) - Medical Device Manufacturing

The Professional

Bachelor’s degree in Engineering, Business Management, Quality, Supply Chain Quality or equivalent, expert or 10+ years of experience in industry-standard quality management practices to implement Quality Management System (QMS) Software along with one of our valuable customers.

Mandatory experience in Medical Device Manufacturing industry, ISO 13485 and FDA (i.e. CGMP) requirements.

Experience and licenses a plus but not mandatory: 5+ years of experience in QMS software implementation, Lead and/or Advanced Internal Auditor Certification for ISO 9001, ISO 13485.

The Role

Professional Services Consultant to perform customer process discovery, requirements gathering for software configuration, documentation, testing, validation and training.

Computer skills

Familiarity with Windows Server operating systems, database applications, basic MS Office and enterprise QMS systems.

Soft skills

Excellent communication, facilitation, documentation, organizational, persuasive and flexible. By nature of work, a PS Consultant must think on his/her feet, and be prepared to adapt to changing situations.

Key Competencies

Quality management system & processes, quality standards, time management, and business analysis.

Position Details

First engagement: single project, one customer location, 3-6 months project timeline.
Ability to travel: 75% of the time.
Remote work: <10%
Workload: full allocation (+40 hour/week)
Type of Contract: (1099) potential contract to hire (W2) based on performance and business opportunities.
Compensation range: $90,000 to 120,000/year
Hiring Manager: Sidney Porto
Resumes Submission:
Contact: (843) 473-2358 or (843) 608-3133