Supplier Quality Specialist

  • Full-time
  • Department: Quality Assurance and Regulatory Affairs

Company Description

LGC Clinical Diagnostics, Inc. is owned by LGC Group, a UK-headquartered life sciences measurement and testing business with >$510m of annual revenue and >3,500 employees globally. 

LGC Clinical Diagnostics Business Unit is comprised of our operating entities including LGC Clinical Diagnostics, Inc. (f/k/a Maine Standards Company & SeraCare Life Sciences), Technopath Clinical Diagnostics, the Native Antigen Company, API & Thistle QA. Our 400+ employees operate FDA- registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), an ISO 9001-accredited facility in Oxford, UK and ISO 17043 facilities in Michigan (USA) and Johannesburg, South Africa. 

We are committed to improving patient healthcare by offering products and services that support accurate and reliable diagnostic results. 

Job Description

 

Role:  

The Supplier Quality Specialist will be responsible for overseeing and managing primarily the process for control of Supplier/Service Providers, Economic Operators and Distributors to TCD and support all other aspect of the Quality System, auditing programs and perform other duties as required to support Technopath Manufacturing Quality Systems (QA, RA, Quality Support). You will play an important role in ensuring adherence to quality standards, and the delivery of high-quality products. This position requires a strong interpersonal skill and the ability to communicate well.  

 

 Responsibilities: 

  • Manage process for control of Economic Operators to TCD (Suppliers / Distributors / Importers / Authorized Reps).  

  • Liaise with the Purchasing & Business Development groups to identify new Economic Operators as needed. Review suitability of new Economic Operators in accordance to established quality system requirements and approve for use if all require criteria have been achieved.  

  • Collaborate with Purchasing and Legal to ensure the development and implementation of effective quality agreements with Economic Operators. 

  • Monitor existing Economic Operators’ performance on a routine basis.  

  • Communicate with Economic Operators regularly. Establish and develop good working relationships with Technopath Economic Operators. 

  • Support the assessment of non-conforming raw materials received from suppliers. Liaise with Quality Systems to ensure the effective completion of Supplier Corrective Actions (SCAR's) 

  • Conduct Economic Operator quality control audits as required to ensure vendors and their supplies remain in compliance with company requirements and regulatory standards. 

  • Support Incoming Quality Assurance: Maintain raw material specifications (file/update), complete check of raw material certificates of analysis, perform visual inspections. 

  • Coordinate, execute and lead the auditing program by conducting internal audits as well as supplier quality audits as the site Lead Auditor. 

  • Support and participate in external Audits (HPRA, Notified Body Audit, Customer Audits) 

  • Provide support to Non-Conformance, CAPA, Change Controls and Documentation Control activities as required. 

  • Update, review and approval of quality documentation such as SOPs, Material control records, Manufacturing Documentation etc.  

  • Support the Implementation, maintenance and continuously improve applied quality system (FDA CFR 820 and ISO 9001 & 13485) at Technopath Manufacturing. 

  • Perform other duties as required to support Technopath Manufacturing Quality Systems (QA, RA, Quality Support) 

  • Operate within the company’s standard operating procedures and review, maintain and create appropriate procedures. 

  • Maintain a good level of housekeeping in designated areas and observe all Health and Safety at work requirements. 

  • Perform other related duties as required. 

Qualifications

  • B.Sc. in Science/Engineering/QA or related discipline.  

  • Lead Auditor training. 

  • A minimum of 3 years practical experience required in a quality function.  

  • Strong initiative and troubleshooting skills required. 

  • Thorough knowledge of FDA 21CFR820, ISO13485, IVDD98/79/EC, IVDR (EU) 2017/746 and international regulatory requirements. 

  • Familiar with ISO 14971. 

  • Strong interpersonal skills and the ability to communicate well – verbally and in writing – with others. 

  • Excellent attention to detail and ability to prioritise. 

  • Strong initiative and troubleshooting skills required. 

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