Position Overview

Manage QA personnel and in-office activities related to Quality Assurance and the cGMP/ISO Quality System requirements across all divisions.

Essential Job Functions

  • Hire, train and oversee the activities/functions of Quality Assurance personnel. Provide daily guidance and mentor staff in all QA responsibilities.
  • Assist with (or perform) performance evaluations of Quality Assurance team members; provide training and development opportunities for department personnel.
  • Coordinate/oversee Master Control quality system documentation activities including but not limited to creating, updating and approving Quality System Procedures, Keystone’s Quality Manual, department or task instructions, S.O.P.’s and other controlled documents as necessary.
  • Define/clarify requirements of the cGMP, ISO 13485 and ISO 22716 standards and help coordinate Keystone’s efforts for meeting all requirements. Ensure employee GMP, GDP and ISO Awareness training is performed and adequate.
  • Assist the Pharmaceutical Quality Unit Manager and associated department functions and duties, as needed. Ensure cross-training of all activities is performed.
  • Oversee quality complaint handling, MD batch record review, deviation and N/C documentation, and the Corrective/Preventive Action Request system. Assist with investigation and verification activities as needed. Ensure that proper follow-up/closeout of CAPAs, complaints and product event reports are performed in a timely manner and regulatory notification is performed as required.
  • Review quality records and assist with the preparation of trend analysis data periodically, including but not limited to customer complaints, product nonconformances, returns and credits, deviations, change managements, OOS information, CAR/PARs, etc. and report trends and issues to executive Mgmt. as needed. Oversee monthly statistical analysis and reporting of credits issued, for Management’s review.
  • Assist in the preparation and coordination of data for the Management Review Reports and meetings. Ensure Executive Management’s company goals and objectives for improvement and plans for meeting them are documented and efforts measured. Communicate quality planning and risk assessment responsibilities to management personnel as needed.
  • Inform Executive Management of problems found within the quality system, providing guidance and updates on improvements or necessary corrective actions.
  • Oversee internal and external vendor audit activities. Review and approve the audit schedule and assignment of audit responsibilities. Ensure new auditors are properly qualified/trained. Approve audit deviations and reports and advise on updates to audit checklists as necessary.
  • Assist with hosting 3rd party regulatory, customer and ISO Notified Body audits. Help to coordinate audits, responses to findings and resulting corrective action closeout activities.
  • Prepare, revise and maintain device master records / product technical files and create/approve associated technical documentation, review/advise on MD labels and instructions for use, assist with product design/development activities, risk management, validation, and other QS and regulatory requirements and records, as necessary.
  • Handle customer communication as necessary and assist in providing information for customers to meet regulatory requirements.
  • Assist with the review/approval of customer quality agreements as needed.
  • Attend seminars or educational courses and perform research as needed to meet job responsibilities

Qualifications

  • Minimum 3 years of directly related experience with Quality Assurance/ISO Quality System Management experience.
  • FDA cGMP and EU regulatory/ISO standard knowledge for medical devices necessary. Knowledge of cosmetic GMP requirements also needed but available through on the job training.
  • Exceptional interpersonal communication skills-ability to interface and communicate/collaborate at all levels internally and externally
  • Knowledge of Master Control e-QMS Document Management program a plus
  • Writing/editing proficiency
  • Understanding of current ISO 13485 and ISO 22716 requirements and associated QMS and medical device product related standards
  • Demonstrated knowledge of US and foreign QMS requirements, including but not limited to FDA cGMP, EU MDD/MDR, Canadian MDR, etc.
  • Demonstrated knowledge of auditing techniques and requirements
  • Outlook, Excel, Microsoft Word proficiency

Education/Certifications

  • Bachelor’s Degree
  • ISO Quality System and Relevant Standard Training
  • Internal / Lead Auditor Training
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