Stryker
Customer Quality Engineer
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Customer Quality Engineer
Location: Belfast
Contract Type: Temporary
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.
- Support all necessary reporting activities related to the complaint handling.
- Gather and analyse 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:
- 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.
Travel Percentage: 10%
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com
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Work Flexibility:
- Remote: Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.
- Field-based: You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.
- Onsite: Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.
- Hybrid: You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.
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