Senior Compliance Specialist Job Description
The Quality Specialist located in Waltham, MA is tasked with maintaining inspection-ready files by promoting QMS processes and supporting company initiatives. A strong compliance mindset is needed. The Specialist ensures documentation reflects risk-based decision making and actions taken by the team to address problems. Excellent attention to detail will be required to be successful as will the ability to multi-task and prioritize. The Specialist is responsible for working collaboratively in the organization's Quality Event files working in systems that include but are not limited to: CAPA, Issue Management and the Audit program under the direction of the Compliance Manager.
CAPA and Issue Management
- Administering the Issue program.
- Administrating the CAPA system Scheduling regular CAPA meetings to review the status of open CAPAs and associated metrics.
- Supporting CAPA projects by leading or assisting individuals in root cause analysis, investigations, and/or corrective and preventive actions.
- Ensuring CAPA files meet all regulatory and internal requirements.
- Administration of the internal auditing calendar and support of the system.
- Administration and support of the supplier and distributor audit program.
- Administration and support of the Clinical Affairs audit program.
- Leading the management of the backroom activities for external audits.
- Tracking any nonconformances, audit findings, and opportunities for improvement through to closure.
- Provide monthly updates and metrics for the internal and external audit systems.
- Interfacing with all departments to ensure the quality system is implemented and effective.
- Lead groups in improvement projects to ensure continued compliance of the quality system.
- Collects and disseminates key performance data and indicators from processes for communication to the Management Team. Reports to the Organization monthly.
- Works with regulatory affairs to ensure Quality Systems are compliant to meet the organization's obligations.
- Supports implementation of our Client'squality management system and ensure compliance to the QSR, MDD, ISO 13485, and the Quality Manual.
- As a member of the Compliance team, this individual (along with others) performs a key role during periodic regulatory audits.
- Helps administer the Change Management process.
- Analyzing Quality Management System data and compiling Management Review Slides
- Revising Quality System procedures as needed
- Cross-functionality - Assisting in other QMS systems and processes to support key function as needed.
- Bachelor's degree, preferably in a science or related field. 8+ years in a Medical Device/Combination Product background is required
- Must have excellent documentation skills.
- Attention to detail and accuracy a must.
- Medical device experience and working knowledge of QSR.
- Medical device complaint experience preferred.
- Experience with validated e-Quality Management software or tools and a minimum of 2 years of compliance-related experience in a regulated industry.
- A working knowledge of the Microsoft Office suite of products (Excel, PowerPoint, Word, Project and Visio) needed. An advanced knowledge of data manipulation with Excel is desirable.
- Team player, good written/oral communicator.
- Able to thrive in a small, entrepreneurial environment.
- Must be organized and able to coordinate activities with internal departments and outside vendors.