Quality Assurance Specialist
hace 4 semanas
We are seeking a highly skilled Quality Assurance Specialist to join our team at MG STAFFING GROUP. The successful candidate will be responsible for providing oversight and guidance on the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and regulatory requirements.
Key Responsibilities- Provide expertise and guidance on interpreting policies, regulatory and/or governmental regulations, and agency guidelines to ensure compliance.
- Work directly with operating entities to provide process analyses oversight and enforce requirements and meet guidelines.
- Lead audit and inspection preparation, resolution of audit and inspection findings, and liaise with auditing groups and inspectors.
- Coordinate legal requests in support of government investigations or litigations.
- Ensure the quality assurance programs and policies are maintained and modified regularly.
- Minimum 2 years of experience working with Quality Management Systems in the regulated industry (Medical Devices).
- Experience in Trackwise and MAP Agile tools.
- Bachelor Degree Completed.
- Strong understanding of global regulatory requirements for medical devices, including FDA regulations (e.g., 21CFR Part 820), ISO 13485, Medical Device Directive, and European Medical Device Regulation.
- Experience defining, driving, and implementing process improvement and functional excellence efforts.
- Strong organizational skills and time management skills.
- Ability to multitask, support multiple projects, function globally, prioritize, conduct team meetings, and meet project deadlines.
- Proven experience in achieving results through influence management and motivating teams.
- Good communication (oral and written), presentation, and interpersonal skills.
- Ability to work in a team environment as well as independently.
- A continuous improvement mindset.
- Exhibits high degree of initiative and good judgment.
- Experience working with Change Control, CAPA, documentation, audit, and/or training.
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