Co-Op Student - Customer Quality Engineer
Stryker Belfast, Northern Ireland, United Kingdom
Responsible for continuous product and process quality improvements. Ensure compliance to regulation and standards. May support 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.
Gather and analyze Post Market trending data (e.g. Q, service reports, complaints, MDR/MIR) to identify opportunities for quality improvement. Support and communicate with complaint handling function to ensure trending information is accurate and up to date.
Provide post-market input and feedback on safety, durability, and reliability design input specifications for Quality report, design reviews, risk analysis, and customer research. Support on PSUR. May support field action related activities i.e., investigations, PFAA, HHEs, etc.
Familiarity with ISO 13485, 14971, GDP, GMP desired. Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics). Knowledge of statistical methods and application. Understanding of US and International Medical Device Regulations.
Key Responsibilities:
* Gather and analyze Post Market trending data to identify opportunities for quality improvement
* Support and communicate with complaint handling function to ensure trending information is accurate and up to date
* Provide post-market input and feedback on safety, durability, and reliability design input specifications
* Support on PSUR
* May support field action related activities
* Familiarity with ISO 13485, 14971, GDP, GMP desired
* Knowledge of Quality Concepts
* Knowledge of statistical methods and application
* Understanding of US and International Medical Device Regulations
Pay rate will not be below any applicable local minimum wage rates.
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.
Stryker is an Equal Opportunities Employer.
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