Job Description
Job Description
Job Summary
We are seeking an experienced Quality Systems Specialist with a strong background in Medical Device Quality Management Systems (QMS) to support global quality compliance initiatives. The ideal candidate will have hands-on experience with FDA 21 CFR Part 820, ISO 13485, EU MDR, ISO 14971, and quality process harmonization across cross-functional teams. Experience supporting Class II Medical Devices and Software as a Medical Device (SaMD) environments is highly preferred.
Key Responsibilities
- Support the development, implementation, and continuous improvement of the global Quality Management System (QMS).
- Ensure compliance with applicable medical device regulations, standards, corporate procedures, and quality requirements.
- Conduct gap assessments of local procedures against corporate quality requirements and regulatory standards.
- Collaborate with cross-functional teams, including Quality, Regulatory Affairs, and R&D, to harmonize and standardize quality procedures across global sites.
- Drive updates to local procedures to ensure alignment with regulatory and corporate requirements.
- Support quality system initiatives involving design controls, purchasing controls, validation activities, CAPA, and nonconformance management.
- Participate in continuous improvement initiatives using quality tools and methodologies.
- Assist with documentation, audits, and compliance activities as required.
Required Skills & Qualifications
- 5+ years of experience in Quality Systems, Quality Assurance, or Regulatory Compliance within the Medical Device industry.
- Strong knowledge of:
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- FDA 21 CFR Part 820
- ISO 13485
- EU MDR
- ISO 14971
- IEC 62304 (preferred)
- Experience developing and implementing QMS procedures, including:
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- Design Controls
- Purchasing Controls
- Validation
- Nonconformance Management
- Corrective and Preventive Actions (CAPA)
- Experience performing gap assessments and quality process harmonization.
- Proficiency with quality tools such as:
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- Root Cause Analysis
- Six Sigma
- FMEA
- SPC
- Risk Management
- Strong collaboration and communication skills with cross-functional stakeholders.
- Experience with enterprise quality systems and ERP platforms such as SAP or EtQ.
- Must be proficient in Microsoft Office Suite.
Preferred Qualifications
- Bachelor's degree in Engineering, Science, or a related technical discipline.
- Certified Quality Engineer (CQE) or equivalent certification.
- Experience supporting Software as a Medical Device (SaMD).
- Experience with Class II Medical Devices.
- Technical, engineering, or scientific background preferred.
\nCompany Description
Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.
Company Description
Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.