Assists in assuring medical devices are designed and manufactured with high quality and reliability, within all domestic and international regulatory Quality Management System (QMS) requirements and meet or exceed customer expectations.
ACCOUNTABILITIES - • Plans and conducts inspection of equipment validations. • Responsible for the Environment Monitoring Program • Responsible for monthly/quarterly/bi-annual/yearly product testing and analysis of data • Collaborate with Post Market Surveillance - Investigations, track and trend of complaint data, PFA/HHE meetings • Yearly Periodic Risk Assessment review • Assist with external/internal audits • Update create SOPs/ECOs and any related documents • Interact with other departments to resolve development, manufacturing and/or customer issues. • Leader model and coach other team members in EBS and QA
KNOWLEDGE, SKILLS & EXPERIENCE -
Critical Knowledge and Qualifications: what the role holder must know; including any required general or professional qualifications/ education) • Bachelor's degree from a four-year College or University in an engineering discipline. • Compliance certifications highly preferred. • Must have knowledge of basic computer software applications such as Microsoft Word, Excel, PowerPoint, etc. or equivalent. • Must be available to work in a flexible working environment • Must have SAP knowledge • Knowledge of ISO standards • Internal/External audits • Quality seminars, webinars and other quality events
Critical Skills/technical know-how: /what the role holder must be able to do. • Ability to analyze trend data on quality systems metrics using standard statistical techniques such as Minitab • Must have good project management, communication and collaborative skills working individually or with various functional teams • Must be hands-on and able to multi-task to address existing and potential QA issues routinely.
Critical Experience: • General FDA and international medical device regulations knowledge (i.e., 21 CFR Part 820, ISO 13485, MDD, JPAL and CMDR)