Supplier Quality Engineer

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Job Ref: J22767
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 20 July 2017
  • Hertfordshire, England, UK
  • £40,000 - £60,000 per Annum
  • Laith Mustafa
  • 0161 868 2200

Supplier Quality Engineer - Medical Devices - South EastSRG are currently recruiting for a Supplier Quality Engineer to join a global Medical Device company. Working in partnership with the Global Supplier Network on activities around the supplier evaluation and assessment, you will be responsible for the planning, leading, execution and post-processing of supplier QMS and process audits. You will ensure a dynamic audit process such that audits can focus on process and QMS, thus meeting compliance and product quality requirements. You will perform supplier quality audits in accordance to 21CFR 820, ISO 13485, and other applicable standards to assess and ensure compliance accordance to manufacturing process and product specifications. You will lead pre- and post-audit activities by involving all relevant stakeholders of different functions within global teams. You will have a supporting role to close effectively and timely nonconformities cited during supplier auditsKey tasksWithin the Global Supplier Quality Organization you will be working independently and in the Global Supplier Quality Audit team. You will be responsible for activities including; Responsible and accountable for the planning, leading, execution and post-processing of supplier process, product and QMS audits. You will ensure a dynamic audit process such that audits can focus on process and QMS, thus meeting compliance and product quality requirements. Identify and communicate issues that may impact product quality, system gaps or business continuity and ensure these issues are effectively and promptly contained and addressed. Complete audit reports and communicate with internal teams and suppliers within the time frame per internal procedures and ensure all audit findings are effectively contained and communicated to supplier and internal partners. Accountable for post audit activities including timely closure of all audit deficiencies. Maintain supplier audit files and ensure all records are filed on time per procedure requirement and are compliant to defined requirements. Work closely with the SQM Partners in order to continuously improve the product quality, delivery and systems at the supplier base. Accountable for audit metrics to ensure compliance per procedure requirements and objectives. Develop/modify the audit process, procedures and audit checklists as regulatory requirements change or as a result of continuous audit process improvement. Participate in Business Development activities like Mergers & Acquisitions and perform due diligence audits. Create and foster a strong working relationship with the different Global Supplier Quality functions, Strategic Sourcing and additional key interfaces to facilitate effective collaboration. Qualifications/knowledgeProfessional Requirements-* Bachelor's Degree in Engineering or Science fields* Minimum of 3 years' audit experience in regulated manufacturing environment.* Strong working knowledge of QMS and process audits Lead Quality Auditor Qualification/Certification in ISO13485 or comparable industry standards and regulatory requirements. Furthermore you are familiar with GMP, ISO 13485, 21 CFR Part 820 standards. Demonstrates ownership of and ability to lead multiple tasks to prioritize and complete supplier's audits in a timely manner and within budget Must demonstrate strong ability to work independently to effectively work to meet audits timelines and reporting requirements Must demonstrate the ability to plan, organize and implement multiple concurrent tasks Strong communication skills. Must demonstrate the ability to communicate up/down and across different levels of the organization. Fluent written and oral EnglishProfessional Requirements- Desirable: Preferred audit experience with aviation, aerospace, automotive, defense as well as medical device industries ASQ CQE/CQM/PE certification Experience in Tissue Banks and test Laboratory Systems/ process auditsPersonal Competencies Demonstrated strong influencing and communication skills.  Demonstrated professional manner and effective interpersonal skills with an ability to overcome language and cultural barriers Highly motivated and able to build close relationships internally and externally. Demonstrated responsibility and ability to plan, organize and implement multiple concurrent tasks Highly flexible and willing to travel in support of business needs, up to 70% travel is required to different geographical locationsFor more information, please call Laith Mustafa on 0161 868 2231 or email

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.