Sr Quality Compliance Specialist at RCM Technologies in Waltham, MA

Job Description

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.

Responsibilities:

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.

Audit Program

• 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.

Quality System

• 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.

Education:

• Bachelor's degree, preferably in a science or related field. 8+ years in a Medical Device/Combination Product background is required

Requirements:

• 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.