Quality Systems Manager

QUALITY SYSTEMS MANAGER

The Quality Systems Manager will be hands-on and drive the implementation and refinement of the quality management system in compliance with FDA 21 CFR 820 and ISO 13485 standard.  This key individual will provide support involving product design and development, product testing and disposition, quality investigations and cGMP oversight to product manufacturing, evaluation, and release. The Quality Systems Manager may be required to perform all or a combination of the following essential responsibilities as determined by necessity.

Essential Responsibilities:

The Quality Systems Manager will report to the Head of Quality and may be required to perform all or a combination of the following essential responsibilities:

  • Develop, establish and maintain phase appropriate quality systems, policies, procedures and controls ensuring that the quality of products conform to applicable regulatory requirements and company standards
  • Provide guidance to external partners to ensure MFG activities are performed in a compliant manner with company and regulatory expectations
  • Work with the R&D team to ensure compliance to design controls and establish key areas for QA oversight for new products and processes; routinely audit the design history file (DHF), device master record (DMR) and design history record (DHR) documentation.
  • Responsible for managing operational QA systems: change control (Engineering Change Order and Inventory Change Order), non-conforming material, investigations and root cause analysis, CAPA and records maintenance
  • Review and approve executed device history records and all associated documentation
  • Responsible for disposition of products
  • Responsible for the complaint handling process, including receipt, investigation and closure and work closely with Regulatory Affairs relating to reporting.
  • Plan and manage audit programs (internal and external) using risk-based assessments, reporting findings/compliance metrics and implementing appropriate risk escalation and mitigation strategies
  • Implement and manage training program, including managing training plans, training files and records, company-wide cGMP and new hire QMS overview
  • Work closely with Operations to support the supplier management program; qualify and routinely monitor supplier performance and institute Quality Agreements, as required
  • Business Owner/Administrator for the PLM system (Arena)
  • Manage the software validation program for design and manufacturing tools/applications (requirements management, ERP, CRM) and assure that software revisions are appropriately assessed for existing tools in compliance with Part 11/GAMP 5
  • Manage and communicate quality data from multiple sources to assist in the risk management and risk-based decision processes
  • Collect and report on quality metrics via Quality Management Reviews
  • Perform product labeling review/approval
  • Assist with compiling/review of company regulatory submissions
  • Promote and advance a Quality Culture
  • In conjunction with the Head of Quality, host regulatory inspectors  

Experience & Training:

  • Minimum of Bachelor’s (required)
  • At least 5 years of Quality experience required in medical device industry
  • ASQ CQA or CQE certification preferred
  • Working knowledge, understanding and experience implementing 21 CFR 820, ISO 13485:2016, and ISO 14971 processes
  • Expertise with process/software validations
  • Proficiency with Microsoft Office suite; familiarity with Arena desired
  • Possess experience/knowledge of contract manufacturers, distribution, supply chain and logistics
  • Strong compliance audit background
  • Be driven, energetic, with high personal integrity
  • Possess effective written and verbal communication, presentation, facilitation and project management skills
  • Able to manage multiple priorities and execute on time
  • Possess effective leadership skills; able to lead, motivate and inspire others
  • Available to travel up to ~10%, when necessary

Please send your resume to careers@cytrellis.com