Job Description
Now Hiring: Quality Systems Specialist (Medical Devices)
Client Industry: Medical Devices
Contract Duration - 6 months/W2
Overview
We are seeking an experienced Quality Systems Specialist / Quality Compliance Engineer to support the development, implementation, harmonization, and continuous improvement of the Quality Management System (QMS) within a regulated medical device environment.
This role will partner with cross-functional teams to ensure compliance with global medical device regulations and corporate quality requirements while driving standardization and harmonization of quality processes across multiple sites and regions.
Key Responsibilities
- Support the global implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
- Collaborate with cross-functional stakeholders to harmonize and standardize quality procedures, tools, and best practices across sites and regions.
- Conduct gap assessments of local procedures against corporate procedures, quality requirements, and applicable regulatory standards.
- Drive updates and revisions to local procedures to ensure compliance with regulatory and corporate requirements.
- Partner with Quality, Regulatory Affairs, R&D, and Operations teams to align and execute quality system initiatives.
- Support quality compliance activities and contribute to audit readiness efforts.
- Assist in maintaining compliance with applicable medical device regulations and standards.
Must-Have Experience
- Minimum 5+ years of experience in Quality, Regulatory Compliance, Quality Systems, or a related field.
- Prior experience within the Medical Device industry is required.
- Strong knowledge of:
- FDA 21 CFR Part 820
- ISO 13485
- EU MDR
- ISO 14971
- Experience developing, implementing, and maintaining Quality Management System (QMS) procedures.
- Experience supporting quality system elements such as:
- Design Controls
- Purchasing Controls
- Nonconformance Management
- Validation
- Corrective and Preventive Actions (CAPA)
- Strong communication and collaboration skills with the ability to work effectively across Quality, Regulatory Affairs, and R&D teams.
- Proficiency with Microsoft Office Suite.
Preferred Qualifications
- Bachelor's degree in Engineering, Science, Technical, or related discipline.
- CQE (Certified Quality Engineer) or equivalent certification.
- Experience with Software as a Medical Device (SaMD).
- Experience supporting Class II Medical Devices.
- Knowledge of IEC 62304.
- Experience using enterprise quality systems and ERP platforms such as SAP and/or EtQ.
- Familiarity with quality methodologies and tools including:
- Six Sigma
- Root Cause Analysis
- Risk Management
- Statistical Process Control (SPC)
- Failure Mode and Effects Analysis (FMEA)