Quality Assurance Specialist

JOBDESCRIPTION i GLOBAL JOB TITLE: Quality Associate Specialist, Quality, Quality Assurance POSITION TITLE: Assoc Specialist, Quality Assurance REPORTS TO POSITION: Sr Manager, Business Operations and Quality Assurance GENERAL SUMMARY OF POSITION The Quality Associate Specialist position will support the Quality Manager at the UK site in Suffolk and the Global Quality Manager based in Brussels. The Quality Associate Specialist will be responsible for the day-to-day maintenance of the ISO9001:2015 Quality Management System, which delivers all of the UK operational activities applicable to the company performance, system development and certification, using the Sharepoint e-QMS and Office 365 suite. By acting as site SME, the Quality Associate Specialist represents the compliance approach of the operations to the wider group. These activities include the carrying out of routine quality tasks; including supplier & internal quality audits, procedural reviews and updates, complaint approvals, investigations and reporting, complaint data analysis, customer requirement ownership, quality questionnaires & supply chain memos, corrective action reports, manufacturer and supplier corrective action handling, technical support, document control and associated project work. The Quality Associate Specialist shall be responsible for supporting the imputing and accessing of product data and information via a variety of Ansell systems and platforms (full training will be provided) to ensure that staff and customers can gain information effectively and efficiently. This position also holds primary responsibility for assisting in the maintenance and continuous improvement of the Environmental Management System to comply with ISO14001:2015, using the Sharepoint e-QMS and Office 365 suite. Acting as the Environmental Manager, activities shall be carried out to identify, monitor and measure operational risks and opportunities, as well as increasing the awareness of the whole team. This position is responsible for assisting in the implementation, management and continuous improvement of the company management of Health & Safety, using the Sharepoint e-QMS and Office 365 suite. This QSHE role shall involve working collaboratively with a range of key stakeholders, both within the local team of departments, production and quality at the manufacturing site & approved suppliers, and Ansell global teams & project leaders. RESPONSIBILITIES & SPECIFIC ACCOUNTABILITIES Quality Management System - Support & Development – 40% • Lead the initiatives in creating quality plans, meaningful metrics and procedures. • Partner with QA team at all sites to develop and document processes and procedures. • Develop dashboards and targets that feed into the broader Ansell strategy. • Oversee the corrective action / risk rating program. • Assist the Quality Manager to prepare for and conduct customer and supplier audits and perform internal audits as per the approved schedule. • Provide data reports for management review or in support of quality focused activities. Communicate on all global quality matters and provide information as required. • Approve Quality Document Control requirements. • Complete customer requests for information, technical support and quality questionnaires / supply documentation in a polite and timely manner. • Train new personnel on procedures and relevant key quality topics. • Serve as Quality lead for product, systems and project support. Environmental Management System – 20% • Lead the EMS processes and maintain all necessary registers, risk assessments and monitoring activities on site. • Undertake key initiatives to support the ISO14001 system. H&S Management System – 20% • Maintain the H&S processes from a local system to the company reporting and frameworks • Undertake activities which support the monthly reporting to Risk Managers. • Lead the site Safety Committee; arranging and minuting all minutes. • Control the Safety tracker for updates on actions required. • Conduct site Risk Assessments and manage and review as required. Customer Complaint Handling – 20% • Facilitate customer complaint investigations using site procedures and systems. • Review complaint responses and provide approval, as needed. • Work with Ansell colleagues to enable complaint handling globally via the team. • Undertake training towards implementing the Ansell complaints platform system. • Review and delegate necessary corrective tasks associated with closing complaint files, updating records, and recording activities which may need monitoring. Product Support The Malaysian site are responsible for all product manufacturing. Therefore, product QC and QA is managed by the Quality Manager, however the Quality Specialist will be expected to learn about the range of products in order to support the sales and distribution functions of the Newmarket site, from a QA perspective. By understanding the manufacturing processes and release procedures, the Quality Specialist shall be able to act as the link between the supply of products and the customer’s quality requirements. Therefore tasks, after training, will include; • Reviewing product information documents for accuracy and consistency. • Monitoring the availability of lot specific product and compliance information. • Using Smartsheet to ensure up to date product information is recorded and communicated effectively, with changes and updates being managed appropriately. • Analysing and publishing product performance data from multiple sources and highlight trends to the Quality team. • Oversee the initiation, investigation and closure of product and process deviations/nonconformances including the process (non-conforming material) and associated rework activity. • Primary Quality contact for Marketing in developing and maintaining product specifications; manage and update related processes from specification changes. Perform other related duties as assigned by management. KEY POSITION REQUIREMENTS Education • Combination of relevant degree and/or 3-years of Quality or QSHE experience. Job Experience • Min 1 year of experience in an ISO/FDA regulated environment especially PPE or pharmaceutical. • Min 3 years of experience working with Quality Management Systems • Internal Auditing experience. • IOSH or NEBOSH qualification desirable. Knowledge and Skills • Advanced knowledge and skills in using Adobe Acrobat, Microsoft applications, including SharePoint, Word, Excel, PowerPoint, CRM, ERPs. • Experience with Smartsheet beneficial. • Highly detail-oriented and organized with the ability to multitask in a fast-paced environment. • Highly collaborative and able to give/receive critical feedback. • Ability to critically analyze and make independent decisions and recommendations.