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Product Quality Engineer

Job LocationBristol
EducationNot Mentioned
Salary£40,000 - £45,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Fast growing Femtech leader Elvie are looking for a Quality Engineer to develop product quality.Client DetailsWe develop smarter technology for women and are committed to building extraordinary products that improve womens lives.Its a fascinating and challenging area to be addressing as it requires all our employees to stretch themselves and solve problems that no-ones tackled before. Thats why were looking for skilled, curious individuals who want to grow by surrounding themselves with a diverse array of outstanding people.Our street cred includes more than 12 awards for innovation and design, including the prestigious CES Innovation Award, IDA Design Award and Red Dot Award.As a business, Elvie has received more than 30 awards (including a prestigious Red Dot design award), was named one of 15 startups "To Watch" by The Sunday Times and Business Insider, ranked as the 13th fastest growing business in the UK by SyndicateRoom. Tania Boler has recently been rated as the 8th most influential people shaping british technology in 2019 by Business Insider and both products have been featured in the Oscar Nominee Gift Bags.In April 2019, Elvie announced a $42 million , bringing the total raised thus far to over $50 million. Our Series B represented the largest ever fund-raise in Femtech. This new round of financing accelerated Elvies research and development efforts, and has helped grow brand awareness and distribution. That growth is expected to continue into 2021 with ambitious plans and new exciting product launches.DescriptionReporting to the Head of Manufacturing, as Product Quality Engineer you will work within a team of multi-skilled engineers, supporting new product introduction, current manufacturing and in-field reliability.The role will involve (but not be limited to):Product Industrialisation / Transfer to Manufacturing

  • Support the introduction of new products into global contract manufacturing plants alongside the Design Quality, NPD, Manufacturing and Operations teams
  • Participate in design reviews, actively feeding in lessons learnt from similar and/or previous products as well as supporting DFM/A activities
  • Qualification of in-line test equipment alongside the manufacturing teams (Gage R&R)
  • Review and sign-off of supplier IQ, OQ, PQ activities (where applicable)
  • Lead part and process qualification activities to ensure products are fit for large scale manufacture - including but not limited to the running of studies, creation of documentation, and review and approval of documentation, reports and CM led studies.
  • Continually assess the product introduction process and identify opportunities to improve consistency and quality whilst optimising the available resource and reducing cost
  • Production Quality (Current Manufacturing)
  • Act as technical point of contact for the CM for all quality queries, tasks and activities
  • Manage batch release inspections and associated inspection data
  • Supporting the Design Quality, CI and Manufacturing team with change management and production cut-in activities
  • Field Quality
  • Ownership of designated product platforms
  • Proactive, hands-on investigation and inspection of defect products/parts
  • Responsible for understanding field performance and trends across all sales channels and regions - drivers of returns and replacements understood
  • LeadingCAPA actions and investigations
  • Management of supplier and product quality issues
  • Escalation of design issues to CI team for resolution
  • Escalation of channel behaviour drivers (non-defect) to relevant departments
  • Supplier Management
  • Support supplier assessment and audit activities alongside SQA team
  • Champion and enforce Chiaro supplier management and best practice processes when working alongside contract manufacturers
  • Participate in regular supplier performance reviews
  • Data Analysis
  • Support the introduction of improved product quality data systems
  • Monitor and lead internal reviews of monthly data sets
  • Identification of issues, changes in trends and opportunities for improvement
  • ProfileWe are looking for a hands-on and proactive product focused Quality Engineer who will be involved in the product life cycle from cradle to grave. You will have experience managing product quality in a similar business/industry which utilises a contract manufacturing business model and understand the intricacies of manufacturing products with overseas suppliers. Requirements
  • Natural leadership and ability to bring together the right people at the right time
  • Good grounding in quality engineering practices
  • Experience working in a medical device regulated manufacturing environment in compliance with ISO 13485 and ISO 14971 advantageous
  • Process Excellence / Six Sigma certification desirable
  • Mechanical and electrical fault finding
  • Broad manufacturing experience across a range of materials and processes
  • Strong working knowledge of Quality tools, techniques and theories - Gage R&R studies, FAI reports, Capability studies, DFMEA, PFMEA, control plans, P-Flow, auditing techniques, SPC, RCCA/8D, 5 Why
  • Experience with an electro-mechanical assembly environment
  • Knowledge of medical device product introduction and manufacturing requirements (IQ, OQ, PQ / GMP etc)
  • Experience of working alongside and managing global manufacturing partners across varying time zones and cultures
  • Ability to audit manufacturing plant capability and production lines
  • Flexibility to travel internationally to support product introduction and manage manufacturing improvements projects
  • An ability to set expectations and stay calm and positive under pressure
  • Clear and concise communication
  • Ideally, time with a start up that has gone through the scaling process
  • Job OfferExcellent benefits and working culture.

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