Cache of job #14131195

Job Title

Quality Assurance Specialist

Employer

Sanderson Recruitment

Location

Offaly

Description

This company is a global medical device company & evolved into one of the world's leading global medical technology organisations providing a range of unique and vitally important equipment. Responsibilities: The QA Specialist will be responsible for Quality Management System (QMS) Implementation & maintenance. Review of corporate procedures to manage & review of QMS procedures. Leading meetings to ensure KPIs delivered, updated & reported. Update on KPI's both internally & externally as required. Ensure Auditing of QMS at all times. Complaints: Lead complaints review & fix process - use of complaint defect codes to trend data. Manage trending, investigation, corrective actions from complaint data & reviews. 3rd Party Inspections. Support, help preparations and be on site for 3rd party QMS audits & by 3rd party auditors. Maintain database to ensure audit ready at all times. Support Electrical safety audits as required. QMS process. Manage routine QMS process including internal Audits - schedule, execution & follow up. CAPA review board - schedule, execution & follow up. Document Control support & devt. & Continuous improvements. Qualifications: Engineer/Science qualification (Minimum BSc or BEng) with min 2 years in QA in a multi-national medical devices manufacturing environment. Excellent working knowledge of ISO 13485 & 21CFR820 & MDSAP program, along with exposure to other regulations. Working familiarity with IEC 60601 a distinct advantage. Exp. in external Regulatory bodies to manage certification & audit program including following up actions of Quality Mgt. System. Exp in working within a CAPA program, & other QMS; leading several projects in tandem. Accurately scope projects & consider full impact of decisions & actions taken. Attention to detail & accuracy - essential. Work well under deadlines & pressure; Strong problem solving skills objectives required. Exp in Six Sigma & lean techniques & statistical analysis a distinct advantage. An excellent Salary and benefits on offer.

Date Added

1161 days ago

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