Supplier Quality Assurance Controller

Inspiration Healthcare Group Croydon United Kingdom Quality Assurance & Regulatory Affairs
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Company Description

Inspiration Healthcare is a British based, global provider of medical technology, and our mission is to pioneer medical technology that improves outcomes of patients, starting with the very first breaths of life.

We provide high-quality, innovative products to patients around the world that help to improve patient outcomes, and we actively invest in innovative product opportunities, disruptive technologies and, of course, our people.

The Group currently consists of three companies: Inspiration Healthcare Ltd, SLE Ltd and Viomedex Ltd and, under these brands, we sell neonatal intensive care and operating theatre equipment around the world through a network of distributors into over 75 countries.

We also offer a full range of ambulatory infusion care devices for both hospital and homecare applications to customers across the UK and Ireland.

Products range from highly sophisticated capital equipment through to single-use disposables all of which can help improve outcomes of extremely sick patients.

We can proudly admit that we haven't come this far without entrepreneurial spirit, a solution driven attitude, and a determination to improve outcomes for premature and sick babies. So if making a positive difference to other people's lives resonates with you and you believe that you have what it takes to flourish and succeed in this role, then we’d love to hear from you.

Position

Job Purpose (Role Definition):

Responsible for the inspection of goods, in-process materials and final products to ensure quality requirements are met. Supports in the selection, approval and maintenance of SLE’s approved suppliers by performing supplier quality system assessments, monitoring supplier performance, and driving supplier corrective action and/or improvement


Main Duties and Responsibilities

  • To provide accurate and timely processing of brought in goods, liaising with the materials, production, Service and other departments where appropriate.
  • Liaise and consult with suppliers on rejected materials ensuring a timely resolution. Ensure all internal interested parties are aware such as purchasing, Materials, QA and Engineering where applicable.
  • Perform final product specifications and release activities to ensure products meet defined quality requirements.
  • Verify status of any concessions raised on finished product. Check required paperwork and/or company databases including traceability details have been completed.
  • Assist with the review of nonconforming materials, raise non-conformance records, quarantine, processing and effective dispositioning of non-conforming materials, and track progress of actions required to resolve non-conformities.
  • Ensure that materials and products within inspection and quarantine areas are appropriately controlled, identifiable and traceable.
  • Assist with management of quarantine materials, effective disposition of materials
  • Assist with the Management of Internal Non-Conformances (including root cause investigations and CAPA)
  • Consult with suppliers on quality issues from failures
  • Assist in internal Audits – ISO13485:2016
  • Assist in the assessment of potential new suppliers and service providers for quality and quality system capabilities through the execution of audits, and review of other objective evidence, as required.
  • Assists with on-site quality assessments of new suppliers, as required, and ensures appropriate corrective action response to findings.
  • Ensures correct documentation of supplier approval process
  • Provide accurate processing of all non-conforming product returns to suppliers, liaising with the Materials and Quality Engineers as appropriate
  • Assure CAPA plans are executed for nonconforming supplied material and works with the supplier on the investigation and resolution of root cause issues
  • Notifies suppliers of customer complaints related to failures resulting from supplied material and requires investigation and corrective action.
  • Monitor supplier performance and reports on quality trend data
  • Recommends and participates in improvement projects, as required, to improve supplier performance

Management Responsibilities

None

Requirements

Experience and Qualifications Required

Mandatory

  • Educated to at least “A” level standard, HNC / HND or equivalent
  • Strong background and experience of electronic document management systems, such as Trackwise Digital, Q-Pulse or similar.
  • Experience of manufacturing and quality control inspection activities
  • Experience, knowledge and application of QARA procedures and processes as related to supplier performance

Desirable

  • Experience of working in a small to medium sized company;
  • Lead Supplier Auditor qualification
  • Knowledge of quality tools such as 8D, fishbone diagram, 5 whys, RCA, CAPA, Six Sigma, LEAN manufacturing
  • Knowledge of ISO13485:2016

Key Skills and Competencies

  • Passionate about ensuring efficacy of medical devices and playing an integral part in a multi-disciplinary team;
  • Excellent attention to detail;
  • Highly organised with excellent attention to detail;
  • Proactive in improving QARA department Supplier performance and control processes;
  • Good time management and effective at meeting deadlines;
  • Good interpersonal and communication skills

Other information

As well as being dedicated to providing a great place to work in a rewarding, stimulating and environmentally conscientious environment, we offer an extensive range of benefits, listed below, and actively support learning and development opportunities for all:


  • 25 days' holiday pa, rising to 28, plus bank holidays
  • Compressed 4 day week & blended working options
  • Enhanced pension scheme (with salary sacrifice option)
  • Bonus schemes
  • Sharesave scheme
  • Mind & body wellbeing support
  • Healthcare cash plan
  • Retailer discounts
  • Life assurance
  • Enhanced and equal leave & pay for new parents
  • Cycle to Work
  • SmartTech scheme
  • Electric Car Benefit
  • Employee referral scheme
  • Travel season ticket loan