Our client is looking for a Quality Engineer level 3 to join them to support an ongoing project onsite.
Responsibilities
Takes a preventive approach to Quality Assurance, proactively identifying potential issues.
Uses strong organisational skills and effective time management to ensure work is completed in a timely manner.
Effectively prioritises a diverse workload to ensure timely completion of critical tasks.
Plans and executes both daily tasks and long-term projects to ensure timelines are met.
Takes a pragmatic and logical approach to challenges faced.
Explains technical topics clearly to diverse stakeholders through effective communication.
Promotes a culture of continuous improvement through reflection and factoring in previous learnings.
Makes informed decisions related to product quality, including dispositioning non-conforming product.
Evaluates complex quality issues and selects the most appropriate problem‑solving tools/ techniques.
Documents non‑conformances using a high standard of technical writing.
Reviews Complaints' signals and completes investigations for individual events/ unfavourable trends.
Familiar with BSC Quality Systems and ISO/MDD/MDR standards.
Involved in internal and external audits, including audit facing and presenting processes/ documents to auditors as a subject matter expert.
Knowledgeable on Risk Management, Design Outputs and product/ process Risk Documentation.
Uses appropriate statistical tools for sampling, capability, trend analysis, and control charts. Effectively interprets and presents conclusions drawn.
Participates directly in a new product/technology transfer, ensuring compliance to all internal and regulatory requirements.
Uses knowledge of Six Sigma, Statistical Analysis and Lean Principles to solve problems effectively.
Involved in change control for work instructions, protocols/ reports and technical documents, either as a change owner or quality approver.
Evaluates new equipment/processes/chemicals for safety and environmental impact/effect, in conjunction with EH&S.
Completes validations for processes/ test methods in line with requirements and best practices.
Maintains relationships and gives technical guidance to Quality Engineers and Quality Technicians.
Deals with suppliers, other engineering disciplines within and outside of the site as required.
What we need from you
A Level 8 Degree (240 Credits) or equivalent in a STEM discipline.
A minimum of 5+ years relevant experience, within the Medical Device industry or another highly regulated environment.
Experience in validation activities.
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