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.
