Supplier Quality Engineer

Pe Global

Cork

GENERAL SCOPE OF RESPONSIBILITIES: Provide overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of the companies products. Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes. Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), and international organization for standardization (ISO. Provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management. Ensure External Manufacturers continue to meet Quality requirements with regard to Supplier Change Request process of the company. This position will require travel. QUALIFICATIONS AND EXPERIENCE: A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline. A minimum of 5 years of experience in a highly regulated industry is required. Experience in the Medical Device industry and/or Pharmaceutical industry is required. FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge required. Experience in root cause analysis is required. Please call Lisa O'Sullivan on 021 4297 900 for more info or email your up to date CV to lisa.osullivan@peglobal.net. Supplier Quality Engineer, Job, Cork. This job originally appeared on RecruitIreland.com.

2495 days ago