Cache of job #13623095

Job Title

Quality Engineer

Employer

Lotusworks

Location

Cork

Description

About Us. A valued and trusted partner to the world’s leading companies. We are committed to service excellence through our talented people who are empowered to be innovative and best in class. Location. Based at Ireland’s southwest coast, Cork is home to a large university with pharmaceutical and medical device hubs across the county. From sports, culture and activities Cork has so much to offer! Join us and work with us to deliver the excellent service we are renowned for with our clients. Be part of something great. Your Job Purpose. You will be fully dedicated to the transformation/restructuring project within the company. Your Responsibilities: Work with internal partners and external suppliers. Drive new or revised SPV special process validations as needed with specified suppliers. Support evaluating vendor risk during outsourcing activities. Provide overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of 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. Report on contract manufacturer performance metrics. Handle complex technical issues for manufacturing processes that are to be transferred to satellite facilities. Provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management. Requirements: A minimum of a Bachelor`s degree is required, preferably in an Engineering, Life Science, or related discipline. A minimum of 6years 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. Auditing background is an asset. Blueprint literacy including GD&T is preferred. Experience in root cause analysis is required. Experience or knowledge with machining manufacturing processes and injection molding an asset. Six Sigma, Lean, or ASQ Certification and trainings an asset. This position will require up to 25% travel with occasional international. Strong knowledge of statistical software packages such as Minitab, with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making. Strong mentoring, coaching and leadership skills. Understanding of the NPI (New Product Introduction) process. B enefits. Life Assurance. Pension Contribution. Training & Educational Assistance (Engineers Ireland CPD Members. Healthcare Contribution. Annual GP Check-Up. Extra Annual Leave. Healthcare Screening. Not ready to apply, or have some questions? Call our Talent Specialist’s on 07191-69783 or Email jobs@lotusworks.com and we will be happy to help! Empowering talent we care about for over 27 years. LotusWorks is an equal opportunity employer. This job originally appeared on RecruitIreland.com.

Date Added

2669 days ago

Apply