About this role
<p><span style="color:#020094"><strong>Job Title: </strong>Quality Technician</span></p> <p><span style="color:#020094"><strong>Location: </strong>Southborough, MA</span></p> <p><span style="color:#020094"><strong> </strong></span></p> <p><span style="color:#020094"><strong>ROLE SUMMARY</strong></span></p> <p><span style="color:#020094">To apply quality assurance and medical device regulatory principles and techniques to maintain records, ensure the effective operation of the Quality Management System (QMS) through internal auditing and to approve equipment (scanheads, tables and modules) for shipment.</span></p> <p> </p> <p><span style="color:#020094"><strong>ESSENTIAL DUTIES AND RESPONSIBILITIES</strong></span></p> <ul style="list-style-type:disc"> <li style="color:#020094"><span style="color:#020094">Coordinate and maintain calibration of tools and equipment for all in-house and field technicians with external calibration supplier.</span></li> <li style="color:#020094"><span style="color:#020094">Maintain Device History Records for the purpose of product release. For internal and external manufacturing activities.</span></li> <li style="color:#020094"><span style="color:#020094">Maintain MRB material flow and keep records systematically.</span></li> <li style="color:#020094"><span style="color:#020094">Perform inspections of parts and keep records as needed by Quality/ Engineering function.</span></li> <li style="color:#020094"><span style="color:#020094">Filing and maintenance of Service Records and Customer Files.</span></li> <li style="color:#020094"><span style="color:#020094">Prepare daily and monthly compliance reports for quality, operations and customer support.</span></li> <li style="color:#020094"><span style="color:#020094">Participate in the completion of internal audits.</span></li> <li style="color:#020094"><span style="color:#020094">Assist in document control activities.</span></li> <li style="color:#020094"><span style="color:#020094">Assist in preparation for third party audits.</span></li> <li style="color:#020094"><span style="color:#020094">Perform inspections of modules at supplier sites.</span></li> <li style="color:#020094"><span style="color:#020094">Provide support to the Manager QA/RA-North America for any tasks relating to the quality system and regulatory requirements.</span></li> </ul> <p> </p> <p><span style="color:#020094"><strong>MINIMUM QUALIFICATIONS</strong></span></p> <ul style="list-style-type:disc"> <li style="color:#020094"><span style="color:#020094">Experience with Calibration of Tools and Equipment.</span></li> <li style="color:#020094"><span style="color:#020094">Experience performing first and second party audits.</span></li> <li style="color:#020094"><span style="color:#020094">Ability to produce high quality work under pressure and within tight timescales.</span></li> <li style="color:#020094"><span style="color:#020094">An ability to work within tight deadlines and manage time effectively.</span></li> <li style="color:#020094"><span style="color:#020094">Strong team player with flexible attitude to work priorities.</span></li> <li style="color:#020094"><span style="color:#020094">Excellent computer skills (MS Office applications).</span></li> <li style="color:#020094"><span style="color:#020094">Highschool graduation minimum, bachelors in any technical field or technical certification preferred.</span></li> </ul> <p><span style="color:#020094"><strong> </strong></span></p> <p><span style="color:#020094"><strong>HIGHLY BENEFICIAL SKILLS</strong></span></p> <ul style="list-style-type:disc"> <li style="color:#020094"><span style="color:#020094">Prior Quality Assurance Experience preferred. Lean Six Sigma White/ Yellow Belt a plus.</span></li> <li style="color:#020094"><span style="color:#020094">Medical Device experience.</span></li> <li style="color:#020094"><span style="color:#020094">Close attention to detail.</span></li> <li style="color:#020094"><span style="color:#020094">Excellent organizational skills.</span></li> <li style="color:#020094"><span style="color:#020094">ISO 13485 Internal Auditing training.</span></li> </ul> <p><span style="color:#020094"><strong> </strong></span></p> <p><span style="color:#020094"><strong>BENEFITS</strong></span></p> <p><span style="color:#020094">At Optos, we offer a highly competitive compensation and benefits package.</span></p> <ul style="list-style-type:disc"> <li style="color:#020094"><span style="color:#020094">Eligibility for company bonus program.</span></li> <li style="color:#020094"> <div>The hourly pay range for this position is $29.81–$32.21 per hour, based on experience.</div> </li> </ul> <p> </p> <p><span style="color:#020094"><strong>EQUAL OPPORTUNITIES EMPLOYER</strong></span></p> <p><span style="color:#020094">We are an equal opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation, age or protected veteran status.</span></p> <p><span style="color:#020094">If you feel you have the necessary skills and experience and want to join a great team, please click on the <strong>Apply</strong> button!</span></p>