Design Quality Engineer

Job Description

Market disruptor and leading brand are looking for a new Design Quality Engineer.Client DetailsA very successful award winning medical device business based in Bristol. They are open to modern flexible working patterns. They have proven track record of successful product releases, with one of their products being recognised as an outstanding marketleader. They are keen to grow and develop their product portfolio. They are looking for a Design Quality Engineer to join the business and play a crucial role in their continued progression. The company has a work hard play hard policy and they go to greatefforts to focus on their staffs well-being . A combination of rapid growth and a supportive team has created an excellent environment for career development and progression.DescriptionThe role will involve:New Product Development

• Partner with R&D and supporting functions to deliver new products to market in compliance with required quality requirements and processes.
• Guide the new products and improvement project teams through consistent, compliant and lean delivery according to Design Control and Risk Management processes.
• Support the development of plans, test methods, reports and other quality documentation required for the Design History Files.
• Maintain complete and compliant Design History Files in the eQMS.

Product and Process Continuous Improvement

• Support the continual improvement of Quality System processes and tools that support the product life-cycle.
• Work closely with our Customer Care to recover and correctly interpret insights from the field.
• Help define proposed improvements with our Engineering team and implement proposed improvements with our Manufacturing teams through consistent and robust ECOs.
• Help drive improvements and to create a proactive and functional eQMS with a value-added approach to Quality Management Systems.

Regulatory and Compliance

• Support the development of regulatory submissions for new products and country expansions, including 510(k) and product Technical Files.
• Support CAPA, SCAR and NCR investigation and administration.
• Support the maintenance of calibration activities and records.
• Carry out internal audits when required.

ProfileThis Medical Device and consumer electronic business need a detail-oriented, passionate and dynamic Design Quality Engineer with a desire to be an integral part of their growing Quality team. They need someone who respects the rules and regulations but isnot afraid to do things differently and challenge business as usual. They need someone who is able to understand the needs and challenges of the cross-functional teams that successfully support and drive products to market; from R&D and Product Development,through Operations, Manufacturing, Sales and Marketing. They need an organised and logical Design Quality Engineer who can form a clear path through the noise when complex decisions need to be made. The Design Quality can develop plans of action and communicatethem with confidence to 3rd party suppliers and the different functions within the business.Ideally you will have experience working within the Medical Device industry, in a Quality and Regulatory focused role. You are excited by the prospect of defining the gold standard for quality, design documentation and document control in a rapidly growingbusiness.Requirements for the Design Quality Engineer:

• A degree in a relevant engineering, design or science discipline (or equivalent qualification).
• Appreciation for all stakeholders involved in new product development.
• Experience in consumer and medical device product design and development.
• Developing Quality Management Systems and the ability to interpret regulations.
• Experience ensuring a high level of compliance with MDD 93/42/EEC Medical Devices Directive, MDR, ISO 13485, 21 CFR 820, and cGMP
• Experience in CAPA investigation and root cause analysis.
• Experience in Risk Management tools and techniques (ISO14971)
• Experience in the use of electronic Quality Management Systems and electronic Document Control.
• Experience in IEC60601-1 and IEC 60601-1-2 would be an advantage.
• Experience in auditing to ISO 9001 or ISO 13485 would be an advantage.
• Able to review and understand hardware, firmware and software requirements and specifications.
• Must be familiar with commonly used productivity & statistical software such as Microsoft Office and Google suite.

Job OfferExcellent benefits package