Staff Quality Systems Specialist I

Job Responsibilities

• Develops applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies.
• Serves as the Site CAPA Leader - Acts as Subject Matter Expert to CAPA end users regarding CAPA content and Trackwise utilization.
• Led site CAPA Board meetings and liaises with the WW CAPA Board to ensure timely completion of CAPA activities and identify areas of improvement/escalation
• Serves as the site Audit Manager - Collaborates with the PS Internal Audit Program Manager to assess risks and ensure site internal audit requirements are met
• Ensures systematic execution of all required internal, external (FDA, ISO, etc.) and customer audits
• Supports pre- and post-inspection activities, which may include but are not limited to hosting and logistics, coaching subject matter experts, record review, and tracking of responses, actions and other audit closure activities.
• Acts as Subject Matter Expert regarding audit process and electronic tools utilization.
• Serves as the site coordinator for Quality Notifications (NCs and Planned Deviations) - Acts as Subject Matter Expert regarding QN content, process, and electronic tools utilization
• Supports end users in meeting timely completion of QN related activities
• Leads or supports problem-solving and root cause analysis activities, as needed. Coaches cross-functional teams as a problem-solving subject matter expert.
• Tracks trends of various Quality Data sources (CAPA, Audits, QNs, etc.). Analyzes and reports on metrics.
• Assists with Management Review content development and related activities.
• Maintains Site and WW Quality Systems. Supports continuous improvement initiatives.
• Collaborates with cross-functional partners such as Quality Engineering, R&D, Operations, Medical, Marketing to seek their input into the development of policies and procedures, and their support in addressing Quality Issues.

Education and Experience

• BS degree in in Engineering, Science, or other related discipline
• At least 8 years of medical device, biologic, pharmaceutical, or diagnostic industry experience.

Knowledge and Skills

• Strong knowledge of US and International regulations and standards that apply to the medical device industry including 21CFR820, ISO 13485, MDD/MDR, MDSAP country requirements as well as other requirements applicable to the product.
• Proficient communication, organizational and interpersonal skills.
• Ability to perform multiple tasks and prioritize workload. Self-motivated / directed, require minimum supervision
• Effective analytical, technical, and problem-solving skills.
• Effective meeting and presentation skills.
• Ability to perform and/or host internal / external audits.
• Collaborative ability to work in teams to obtain desired results.