Description

  • Maintains MMQCI’s ISO 13485 certification and prepares input into Technical Files for CE marking of MMQCI products and maintains international product registrations.
  • Prepares and submits FDA pre-submissions, and 510(k) submissions and maintains appropriate FDA registrations.
  • Interprets statutes, regulations, policies and guidance for MMQCI staff teams, communicating how these impact product development, manufacturing, and/or marketing.
  • Remains current on regulatory issues/trends affecting MMQCI products, assessing and communicating their impact to QA/RA colleagues and support teams.
  • Provides training or presentations to cross-functional groups on a variety of regulatory topics.
  • Reviews and approves all MMQCI Quality System documentation to ensure compliance with established procedures and regulatory compliance requirements, including, but not limited to, Master Batch Records, Standard Operating Procedures (SOPs), Change Orders, Material Review Notices (MRNs) and Corrective and Preventive Actions (CAPAs). Works closely with all departments to investigate MRNs and establish CAPAs addressing root cause.
  • Participates in, and may conduct, internal, customer, FDA, and ISO audits.
  • MMQCI staff to review and approve product labeling changes, promotional literature and marketing materials, rework of non-conforming product, CAPA closures, Customer Complaint closures, and Medical Device Reports (MDR).
  • Writes SOPs and trains key personnel as needed.
  • Performs other duties as assigned
  • Education Requirements: Bachelor of Science degree in Life Sciences and at least 5 years of employment in a cGMP regulated facility and at least 2 years of experience in Quality Assurance.
  • Excellent proof-reading skills are required.
  • Knowledge of current GMP regulation, ISO 13485, and In Vitro Diagnostic Regulation (IVDR) is required.
  • Experience in laboratory medicine is highly preferred.
  • Good communication skills, written and oral, with excellent computer skills. Strong work ethic with the ability to work in a dynamic environment with changing priorities.
  • Ability to meet challenging timelines, in spite of obstacles.
  • Willingness to learn and pitch in as part of team.
  • Ability to communicate clearly and constructively to correct non-conforming behaviors and practices.
  • Must be a nonsmoker due to product contamination prevention requirements.


 

Key Skills
Education

Bachelor's degree

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