Cache of job #13621374

Job Title

Quality Engineer - Start Up

Employer

Sigmar Recruitment

Location

Galway

Description

Medical Device Start - Up Vacancy: Quality Engineer required for a leading Start-Up in Galway. Interested candidates please call Fiona McLoughlin on 091 455303 / fmcloughlin@sigmar.ie. Responsibilities: • Has responsibility for conducting all incoming, in-process & final inspections and supporting testing / validation commitments as required. • Issues batch documentation to Production including data record sheets, labels etc. upon start-up & carries out line clearance as required. • Generates NCRs and CAPAs for product defects and non-conformities observed on-site and at all clinical sites and follows up to ensure effective closure. • Supports the management of all calibration and maintenance programs for all equipment. • Maintains the Design History Files for all projects as per ISO Requirements. • Interfaces with all departments (Production, Design & Clinical) on product development / improvement projects as required. • Manages all change requests in a timely manner and ensures effective closure. Qualifications: • Ideally will possess Degree / Post-Grad in Quality Management. • 3 / 4 years experience in a medical device manufacturing environment with direct experience in a QA role and with exposure to FDA / ISO13485 / CE Registration Process considered a plus. • Experience with involvement in Regulatory submissions would be an advantage. • Excellent interpersonal and communication skills. • Strong project management skills and attention to detail combined with proven consistent execution within quality, time and cost targets. • Proven ability to work well as part of a team and on own initiative. • Experience / training in problem solving and clinical environment considered a plus. If interested, please call Fiona McLoughlin on 091 455303 or send your CV to fmcloughlin@sigmar.ie. This job originally appeared on RecruitIreland.com.

Date Added

2671 days ago

Apply