Engineering Change Control Specialist - Remote

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<p><strong><u>OVERVIEW</u>:</strong></p><p><br></p><p>Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished <strong>Engineering Change Control Specialist - Remote.</strong></p><p><br></p><p><strong>** JOB ID:</strong> <strong>52583 </strong></p><p><br></p><p><strong>** JOB TITLE: Engineering Change Control Specialist - Remote</strong></p><p><br></p><p><strong>** LOCATION: Remote Role | Client Location: 17200 Laguna Canyon Road Irvine CA 92603 </strong></p><p><br></p><p><strong>** DURATION: 12 months + </strong></p><p><br></p><p><strong>Pay Rate: $53.00/hr. - $56.00/hr. (depending upon experience)</strong></p><p><br></p><p><strong><u> </u></strong></p><p><strong><u>Job Summary:</u></strong></p><p><strong><u> </u></strong></p><p>The Engineering Change Control Specialist ensures that all documentation aligns with <strong>BD APM’s Quality System</strong> and complies with relevant <strong>medical device regulatory standards</strong>. This role supports engineering change management processes, evaluates documentation changes, and leads special process improvement projects within PLM systems.</p><p><br></p><p><strong><u>JOB RESPONSIBILITIES: </u></strong></p><p><strong><u> </u></strong></p><ul><li>Evaluate proposed changes and provide compliance-based recommendations.</li><li>Lead and support special projects (e.g., <em>Project PaRTy</em>), driving process improvement initiatives.</li><li>Incorporate approved changes into documentation such as <strong>JDE process sheets, drawings, part numbers, and technical summaries</strong>.</li><li>Review change packages for completeness and compliance per BD APM procedures.</li><li>Train and mentor team members on engineering change control workflows (CR/CN).</li><li>Review incoming PCNs (Product Change Notifications) for material or datasheet updates and route accordingly.</li><li>Maintain tracking systems for reviewed, routed, and approved PCNs.</li><li>Collaborate with Lifecycle Engineering to refine triage and documentation processes.</li><li>Ensure internal and regulatory compliance with all documentation and approval standards.</li><li>Perform additional duties as assigned by leadership.</li></ul><p><br></p><p><strong><u>JOB REQUIREMENTS:</u></strong></p><p><strong><u> </u></strong></p><ul><li><strong>Education: </strong>Bachelor’s degree with <strong>5+ years</strong> of relevant experience, <em>or</em></li><li>Associate degree with <strong>7+ years</strong> of relevant experience</li><li>Engineering/Technical degree (Electrical or Mechanical) <strong>strongly preferred</strong></li><li><strong>Experience & Skills:</strong></li><li>Proficiency in <strong>PLM systems</strong> (Windchill PLM <em>strongly preferred</em>, Teamcenter <em>preferred</em>)</li><li>Knowledge of <strong>engineering change control workflows</strong></li><li>Strong command of <strong>MS Office Suite</strong> (Excel, PowerPoint, Word, Visio, Project)</li><li>Skilled in <strong>data analysis and reporting</strong> using Excel (VLOOKUP, Pivot Tables) and/or Power BI</li><li>Excellent communication and interpersonal skills</li><li>Strong problem-solving, analytical, and critical thinking ability</li><li>Working knowledge of <strong>medical device documentation standards</strong> and <strong>regulatory compliance</strong> (21 CFR 820, ISO 13485, etc.)</li><li>Familiarity with <strong>CAD tools</strong> (CREO, AutoCAD, SolidWorks, Altium) is a plus</li><li>Ability to read and interpret <strong>engineering drawings and BOM/part structures</strong></li><li>Highly organized, detail-oriented, and capable of working independently in a fast-paced environment</li></ul><p><br></p><p><em>I'd love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction. If you are looking for rewarding employment and a company that puts its employees first, we'd like to work with you. </em></p><p><br></p><p><strong>Recruiter Name: Lalit Malgotra</strong></p><p><strong>Title: Lead Recruiter</strong></p><p><strong>Email ID: lalit.malgotra@ameritconsulting.com</strong></p><p><br></p><p><strong>Company Overview:</strong></p><p><br></p><p><strong>Amerit Consulting</strong> is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally: as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with a service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.</p><p><br></p><p><em>Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.</em></p><p><em>This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.</em></p><p><em>Applicants with criminal histories are considered in a manner that is consistent with local, state and federal laws.</em></p>

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