Job Title: Quality Systems Specialist

Job Description

In compliance with FDA, European MDD/MDR & ISO regulations, the Quality Systems Specialist will perform work under general supervision. The general scope of this position is to assist in maintaining quality compliance, managing new geographies Quality Compliance Assessments, managing actions for the audit findings and CAPAs, assisting with External Standards management process, supporting audit activities and compiling quality metrics. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Responsibilities

• Assist in managing audit findings and CAPA actions.
• Assist in managing overall compliance of the CAPA and audit systems.
• Work cross-functionally with other teams to track and manage Audit findings and CAPA activities from initiation through closure.
• Identify and implement CAPA and audit system continuous improvement activities.
• Assist with audit preparation activities, conduct and follow up of internal and external audits.
• Participate in quality system activities and support internal and external audits as requested.
• Coordinate audit related activities (prepare documents, track audit requests, take notes, schedule conference room, setup communication channels, etc.).
• Communicate with Subject Matter Experts regarding the audit requests.
• Assist with External records management process.
• Assist in managing compliance to the current revisions of the standards.
• Coordinate standard related activities (track current revisions of the standards, follow up with standards owners on the status of implementation activities, maintenance of Standards tracker, etc.).
• Gather information and update as needed to ensure compliance with procedures.
• Assist with New Geographies Quality Compliance Assessment.
• Work with cross functional teams to identify new geographies regulatory and compliance requirements, conduct gap assessments of the QMS to new requirements, determine implementation plans for compliance to the new requirements and follow through on actions till full implementation.
• Assist with quality metrics for trending purposes.
• Collect and log data as requested.
• Assist in preparation of presentations as needed for data analysis purposes.
• Perform QA related data entry and generate reports as required.
• Work cross functionally with other teams to collect information, follow up on tasks, etc.
• Support company goals and objectives, policies, and procedures, QSR, and FDA regulations.
• Other duties as assigned.

Essential Skills

• Audit
• CAPA
• NCR
• Quality Systems
• Managing Audits (Internal & External)
• Data entry
• Quality assurance
• Regulatory compliance

Additional Skills & Qualifications

• Bachelor’s degree and 5+ years of related experience performing Quality System related activities in the medical device industry.
• Working knowledge of cGMP, FDA 820 QSR and ISO or other Quality Systems.
• Proficiency in data compilation, analysis, presentation, and document writing skills.
• Excellent written and verbal communication skills.
• Excellent organizational skills.
• Experience with computer-based applications (MS Word, MS Excel, QAD).
• Strong time management skills and the ability to multi-task in a fast-paced environment.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.

Work Environment

Collaborative working with an immediate 2 team members and an additional 2 - 3 cross functionally!