Work Flexibility: Hybrid or Onsite
What you will do:
Responsible for continuous product and process quality improvements. Ensure compliance to regulation and standards. Conducts investigations into NCs and CAPAs stemming from the products in the field. Knows and applies the fundamental concepts, practices and procedures of the general Quality and Regulatory environment, Post-Market, in particular.
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Support all necessary reporting activities related to the complaint handling
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Gather and analyse Post Market trending data (e.g. Q, service reports, complaints, MDR/MIR) to identify opportunities for quality improvement
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Present Post Market trending data to the business
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Monitor compliance to Quality Procedures and Quality System Regulations and update as necessary.
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Support field action related activities i.e., investigations, PFAA, HHEs, etc.
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Support internal and external audits (FDA, ISO, MDSAP etc.)
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Provide outstanding customer support with investigation updates to internal and external customers
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Support and communicate with complaint handling function to ensure trending information is accurate and up to date
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Lead and/or support NC and CAPA process and NC and CAPA investigations
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Provide post-market input and feedback on safety, durability, craftsmanship, and reliability design input specifications for Quality report, design reviews, risk analysis, and customer research.
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Conduct/Update risk analyses and track all findings, along with development of Risk Management portfolio, as required.
What you will need:
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Level 6 qualification in a science, engineering or related discipline.
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0- 2 years of related experience required.
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Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
Travel Percentage: None
