Stryker
Customer Quality Engineer
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Location: Belfast
Temporary Contract
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.
- Support all necessary reporting activities related to the complaint handling.
- Gather and analyze Post Market trending data (e.g. Q, service reports, complaints, MDR/MIR) to identify opportunities for quality improvement.
- Present Post Market trending data to the business.
- Monitor compliance to Quality Procedures and Quality System Regulations and update as necessary.
- Support field action related activities i.e., investigations, PFAA, HHEs, etc.
- Support internal and external audits (FDA, ISO, MDSAP, etc.).
- Provide outstanding customer support with investigation updates to internal and external customers.
- Support and communicate with complaint handling function to ensure trending information is accurate and up to date.
- Lead and/or support NC and CAPA process and NC and CAPA investigations.
- 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.
- Conduct/Update risk analyses and track all findings, along with development of Risk Management portfolio, as required.
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What you will need:
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- Level 6 qualification in a science, engineering, or related discipline.
- 0 - 2 years of related experience required.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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