Quality Systems Supervisor - Medical Devices
Job description
Reporting directly to the VP QA/RA, the Quality Systems Supervisor leads and supports the development and implementation of LSL’s quality system and compliance programs. Additionally, this position will assure all aspects of the site’s Quality System are in conformance with customer, international and domestic requirements. This role directs multiple Quality Systems functions, including but not limited to: Corrective and Preventive Actions (CAPA); Quality Improvement Program; Training; Management Controls including Management review and Quality Planning; Quality Systems Metrics and Trending - Global Key Performance Indicators (KPIs). Internal and External auditing programs
Duties And Responsibilities
Manages and improves LSL’s Quality Management Systems (QMS), including the development, continuous improvement and implementation of key quality system processes.
Assures compliance to Quality System policies and procedures to ensure compliance with FDA ISO standards
Designs and implements effective quality processes including procedures, documentation systems, CAPA, tools, reporting metrics and measurable improvements that are required to meet quality system standards and customer requirements
Reviews and presents the state of the quality system on a routine basis to management
Develops and manages Internal Audit Program, in conjunction with the VP. This includes the process for planning Internal audits and tracking/trending audit results, developing and monitoring audit schedules, execution of audits, review and issuance of audit report documentation and determining adequacy of corrective actions resulting from audit findings and report to Senior Management – including the planning and implementation of Mock audits and remediation activities
Manages the Corrective Action & Preventive Action (CAPA) Program to assure CAPA effectiveness and works with department leaders to assure timeliness of response to assigned CAPAs within required target dates
Manages document control processes and systems for GMP activities in compliance with internal procedures and policies as well as regulatory requirements – including the routing, review, approval, distribution and archival of new and revised controlled documents to support quality system requirements
Assures controlled documents are periodically reviewed for relevance and accuracy and that actual practices are reflected as defined in applicable procedures
Leads compliance support during FDA and other regulatory compliance inspections
Leads or assists in the formulation and execution of remediation efforts resulting from compliance inspections, FDA Mock Audits, including responses and implementation follow-up
Assists departmental management in the execution/implementation of projects, as requested
Job Qualifications
BS Degree in a Scientific or Engineering discipline; MS preferred
Minimum of 2-3 years of experience in a GMP-related field within a medical device manufacturing facility
Minimum of 3 years managing and leading the Quality System and associated teams at the company or corporate level
Knowledge of global quality systems and regulatory requirements (21 CFR Part 11/210/211/820, ISO 13485, PAL), GMP, SOPs and quality systems
Ability to communicate and work independently with production personnel
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
Experience with FDA (or Notified Body) inspections
Strong ethics to escalate issues in the face of competing priorities
Certified for Lead Auditor, Internal/External Audits preferred