Quality Engineer/Complaints Analyst - Job Ref No HST268

Transcription

1 IF YOU ARE LOOKING FOR A PASSIONATE AND DEDICATED TECHNOLOGY COMPANY WHERE YOU CAN BUILD A CAREER, THEN HEARTSINE MAY BE THE PLACE FOR YOU. AT HEARTSINE, WE ARE CUSTOMER-DRIVEN AND COMMITTED TO EXCELLENCE IN DEFIBRILLATION TECHNOLOGY. WE ARE DEDICATED TO REACHING OUR GOALS UNDER THE GUIDANCE OF HIGH ETHICS, THE DEVELOPMENT OF INNOVATIVE TECHNOLOGY, AND THROUGH THE HIRING OF TALENTED, MOTIVATED INDIVIDUALS. HEARTSINE Technologies Limited, a subsidiary of Stryker, one of the largest medical companies in the world, seeks to invite applications for the following permanent post: Quality Engineer/Complaints Analyst - Job Ref No HST268 An excellent opportunity has arisen within the Quality department of HeartSine Technologies Limited. As Quality Engineer/Complaints Analyst, you will be responsible for managing all aspects of complaint handling including the preparation of Customer Letters and vigilance reporting to all relevant competent authorities within designated timelines. You will also manage the preparation, maintenance, development and distribution of monthly complaint data analysis and trend reports. Carrying out routine investigations into complaint trends and root cause analysis will also be an important part of your role, providing data reports filtered as specified. In addition, you will maintain the complaint database and provide presentation information for Management Review and CAPA meetings. Responsibilities Handle all complaints received by HeartSine Technologies and carry out initial vigilance reporting assessment relating to all relevant national competent authorities. File initial and final vigilance reports to all relevant national competent authorities within stipulated timelines. Compile Customer Complaint letters using the Engineering Investigation Reports and any other relevant data. Maintain complaints database. Maintain all complaint files both on and off site. Produce and distribute monthly complaint reports to all appropriate personnel Carry out data analysis as requested to assist in decision making at CAPA meetings. Provide Root Cause Analysis reports as requested. Participate in design reviews with the development teams when appropriate.

2 Apply sound quality principles such as six sigma, lean, and statistical process control, to drive product quality and process improvement. Who we're looking for: Qualifications & Experience: Essential Bachelor's degree in an engineering or technical science, or equivalent combination of education and directly relevant experience. 3 years relevant experience, with a minimum of 2 years of recent prior experience in a high-tech or FDA/cGMP environment. Desirable 5+ years relevant experience. Advanced degree (MS and/or MBA). Prior experience working with electrical, mechanical, and/or electro-mechanical commodities. General statistical quality tools knowledge with process capability; demonstrated ability to apply six sigma and statistical quality control methodologies. Demonstrated ability to drive and deliver innovative, effective and timely solutions. Responsible To: Quality Manager Location: This job will be based at HeartSine s Belfast facility, Heron Avenue, Belfast. Our Offer: An attractive package is on offer to the successful candidate, having the opportunity to participate in the manufacture of a market leading life-saving product, whilst being part of a rapidly growing dynamic company. You will receive a competitive salary with additional company benefits.

3 To Apply Please send a cover letter and CV to dlirlrecruit@physio-control.com by Friday 24 th February Applications received after the closing date will not be accepted. HeartSine Technologies Limited is an equal opportunity employer and applications are welcomed regardless of race, ethnic origin, gender, sexual orientation, age, political or religious beliefs, disability or marital status.

4 Job Description Job Title Quality Engineer/Complaints Analyst Responsible To Quality Manager Responsible For None Hours of Work Refer to Terms Department/Location Quality Job Summary The job entails processing the initial receipt of complaints received from customers all over the world. Vigilance reporting to all relevant authorities must be carried out within specified timelines. Responses to customers must be drafted using all available investigative information and must be concise and understandable by the customer. The job will also offer opportunities for improving systems in order to improve efficiency, and the detailed analysis of complaint data in order to determine complaint trends and also to suggest improvements Main Duties & Responsibilities Handle all complaints received by HeartSine Technologies and carry out initial vigilance reporting assessment relating to all relevant national competent authorities File initial and final vigilance reports to all relevant national competent authorities within stipulated timelines Compile Customer Complaint letters using the Engineering Investigation Reports and any other relevant data 4 Maintain complaints database 5 Maintain all complaint files both on and off site 6 Produce and distribute monthly complaint reports to all appropriate personnel 7 Carry out data analysis as requested to assist in decision making at CAPA meetings 8 Provide Root Cause Analysis reports as requested 9 Participate in design reviews with the development teams when appropriate 10 and Apply sound quality principles such as six sigma, lean, and statistical process control, to drive product quality and process improvement Any other duties deemed necessary by the Quality Manager/EMEA Director, Quality & Regulatory or General Manager/Site Leader Note: This description is not intended to establish a total definition of the job, and may include all or a selection of the above duties.

5 Person Specification Job Title Quality Engineer/Complaints Analyst Job Reference Number: HST268 Date 13/02/17 Department: Quality Qualities Essential (Those qualities which are essential to perform the job) Desirable (Those qualities which allow the job to be performed to the optimum level) Education/Qualifications e.g. academic or professional qualifications Bachelor's degree in an engineering or technical science, or equivalent combination of education and directly relevant experience. Advanced degree (MS and/or MBA). Work Experience Previous experience required to do the job 3 years directly relevant experience, with a minimum of 2 years of recent prior experience in a high-tech or FDA/cGMP environment. 5+ years of directly relevant experience. Prior experience working with electrical, mechanical, and/or electromechanical commodities. General statistical quality tools knowledge with process capability

6 Skills/Abilities e.g. analytical skills, computer skills Excellent verbal and written communication skills Working knowledge of Microsoft Office Demonstrated ability to apply six sigma and statistical quality control methodologies. Personal Details e.g. leadership, flexibility, team working Conscientious individual demonstrating attention to detail along with high levels of ownership and commitment A good team player capable of delivering results to deadlines Demonstrated ability to drive and deliver innovative, effective and timely solutions. Other Circumstances Special conditions that apply to the job, e.g. need to travel, work away from home etc.