Technical Writer
Lotusworks
Limerick
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. Limerick is the capital of Ireland’s Mid-West region and is noted for its shopping, its dining and entertainment, its historical significance. Limerick has something to offer everybody thanks to its many cultural, historical, architectural, sporting, shopping and business activities. 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. Working with the LotusWorks group as a Technical Writer, you will perform technical writing activities and assist the project engineers in the generation of all validation documentations including URS’s, FAT’s, SAT’s, test plans, deviations and discrepancies. Responsibilities. Update and edit Operations Procedures and Work Instructions, project manuals, project presentations and reports. Provide assistance with Change Control process to ensure that change implementation activities and deliverables are coordinated effectively in order to meet both the TRB and CCB requirements and timelines. Help coordinate FMEA sessions with Engineering as needed. Assist with attachment and upload of deliverables associated with change control. Help with non-critical Validation execution under direction of Engineering. Assist with purchasing and spare parts ordering. Support Engineering with planning and department development. Provide training on quality systems. Manages and monitors the change control metrics. Ensure accuracy and consistency of the technical/validation documentation. Ensure all quality/validation documents are authorized and appropriate compliance approval is gained. Update procedures. Requirements. Bachelor’s degree (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base. Knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry. Understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations. Expertise in the use of Microsoft Word, Excel and Power Point and electronic document management systems. Excellent verbal and written communication skills. Excellent customer service, interpersonal and team collaboration skills are essential. Establishes and manages engagement objectives and expectations, Works independently and/or within team to accomplish job objectives. Suggest and sometimes may implement innovation and continuous improvement within the technical/validation writing process or within the Engineering process. Builds cross functional and cross-departmental support, fostering overall effectiveness. Benefits. Life Assurance. Pension Contribution. Training & Educational Assistance (Engineers Ireland CPD Members. Healthcare Contribution. Annual GP Check-Up. Extra Annual Leave. Healthcare Screening. Refer someone you know for this role and if we hire them you will receive a €250 voucher. (T’s & C’s apply) Click on the following link to Refer Your Friend today! http://www.lotusworks.com/en-ie/refer-a-friend. Not ready to apply, or have some questions? Call our Talent Specialist’s on +3537191-69783 or Email jobs@lotusworks.com and we will be happy to help! LotusWorks is proud to be listed in the Best workplaces 2017. Empowering talent we care about for over 29 years. LotusWorks is an Equal Opportunity Employer. This job originally appeared on RecruitIreland.com.
2231 days ago