Desired skills:QA, Quality Assurance, Manufacturing, Medical DevicesReperio has partnered with a rapidly growing medical device company who are seeking a Senior Manufacturing QA to support quality assurance across manufacturing processes and external suppliers, including contract manufacturers.Responsibilities:Oversee manufacturing quality for electronic and system-level productionLead root cause investigations and manage CAPAsSupport process validations (IQ/OQ/PQ) and documentation reviewsManage supplier quality performance and participate in auditsEnsure compliance with ISO 13485, FDA 21 CFR Part 820, and related standardsDrive continuous improvement and support internal/external auditsRequirements:Bachelor's degree in Engineering, Quality, or a related field3-7 years in QA or manufacturing in a regulated industry (preferably medical devices)Experience with CAPA, non-conformances, and process validationStrong knowledge of ISO 13485 and FDA QSRExcellent communication skills and attention to detailExperience with contract manufacturersCertifications (CQE, Six Sigma, Auditor)Familiarity with QMS/ERP systems (e.g., Greenlight Guru, MasterControl)For more info contact Seamus at Reperio or apply through the linkReperio Human Capital acts as an Employment Agency and an Employment Business.Seamus O'Rawe is recruiting for this role.Why not send us your CV to be kept up to date with the latest jobs or to have an initial discussion with one of our Consultants.Sign up to our newsletter to receive information about the latest jobs we have on offer.
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