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Quality Assurance Lead

TEC PARTNERS LIMITED
Job LocationNorfolk
EducationNot Mentioned
Salary35,000 - 48,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Tec Partners have partnered with a market leading medical device company designing, developing, and manufacturing drug delivery devices across the globe. They are leading the way in drug delivery device innovation, driven by customer and patent demand, offeringthe potential to create new treatments and opportunities worldwide.Quality Assurance Lead Role:As Quality Assurance Lead, you will take responsibility to understand customer and regulatory requirements by partnering with internal and external stakeholders to ensure that all requirements are met on time to the required standards.

  • Leading by example to the quality team and wider business for best practice decisions
  • Maintaining compliance for a specific area keeping track of KPIs
  • Manage non-conformance and quality risks and identify areas of possible improvements
  • Partner with manufacturing and other technical teams within the business to support with verification activities and auditing risk management plans to ensure customer and patient satisfaction
  • Work collaboratively with wider business functions such as supply chain, engineering, commercial and regulatory
  • Act as a lead for any customer interface for a wide variety of quality activities
  • Review and update quality procedures ensuring they meet requirements and best practice ways of working implementing process improvements where possible
Quality Assurance Lead Requirements:
  • A minimum of 3-5 years working in Medical Device, IVD and/or combination product industry ideally focused on NPI/programme support
  • Good working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, GMP, European Medical Device Regulation and QSIT
  • Ability to manage changing priorities adapting to multiple projects at the same time
  • Exposure to Six Sigma and statistical tools desirable not essential
  • Knowledge and application of design control, risk management requirements for medical device/combination products
This is a fantastic opportunity to join a diverse and inclusive business where authenticity is promoted alongside the growth and development where you can further you career in a fast paced environment with likeminded individuals. As part of the opportunity,you will be granted development opportunities, competitive salary options along with an additional benefits package.If this opportunity is of interest, please apply with an up to date CV.

Keyskills :
KPIManagementMedical DevicesRisk AssessmentQualityISO13485

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