Quality Engineer III

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.