Document Control Coordinator II

Working Location: MASSACHUSETTS, WESTBOROUGH Workplace Flexibility: Hybrid For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. "‹ "‹ "‹ Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. "‹ Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus ( . **Please note: All correspondence will be sent from our Olympus domain (@). If you receive correspondence from an entity other than @, it is likely not legitimate. Job Description Document Control team member supporting the coordination and processing of Documentation Changes. Job Duties Support all release and change activity for new and existing products, plus all other controlled documents. Review all types of Changes(ECOs, COs, IMC s, POR s, PRA s)s and supporting documentation for accuracy, maintaining target turn around times as agreed upon with supervisor. Update procedure specification type word documents as required. Perform data entry into the PLM & MRP system as required (Including New Catalog & Item numbers, Bills of Materials, Engineering Changes and Deviations). Work with Document Control team(all sites) and other departments to support quality and standardization of OSTA documentation process. Promote continuous improvement initiatives(how to improve quality, provide better customer service, reduce costs). Partner with Supply Chain Operations Analyst to project manage OSTA POR requirements. Schedule and chair meetings on POR progress, publish status reports on the process. Work with all departments involved to resolve issues. Thorough documentation of the issues and the resolutions are required. Create POR COs and release to Site Doc Control for processing, after receiving an approved POR, within the established time target. Train employees new to the POR process as required to meet OSTA business requirements. Provide cross functional support to meet business needs as required. When Technical Editing needs assistance, provide short term support when Doc Control workload will allow. Function as ERP, MRP, PLM expert. Provide user support on Agile and Oracle; provide training as required. Provide OSTA employee support on meeting Good Documentation Practices based on OSTA QSR documents, ISO 13485, FDA 21 CFR 820. Meet deliverable, support and quality targets as established during yearly PED objectives. Job Qualifications Required: High school diploma or equivalent is required. Minimum of 3 to 5 years related Document Control experience in a manufacturing environment. Understanding of Quality Change Management Process. FDA and ISO experience. Experience with MRP ERP PLM Systems. Preferred: Drafting, Configuration Management training or certifications are preferred. Excellent writing and communication skills. Ability to read, understand and apply information from published process documents. Strong office skills: MS office: Word, Excel, Access; data entry, scanning documents, filing. Team Player, interfacing well with others. Extreme attention to detail and the ability to perform detail checking for long periods of time. Work independently and part of a team. Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on: Competitive salaries, annual bonus and 401(k)* with company match Comprehensive medical, dental, vision coverage effective on start date 24/7 Employee Assistance Program Free live and on-demand Wellbeing Programs Generous Paid Vacation and Sick Time Paid Parental Leave and Adoption Assistance* 12 Paid Holidays On-Site Child Daycare, Café, Fitness Center** Connected Culture you can embrace: Work-life integrated culture that supports an employee centric mindset Offers onsite, hybrid and field work environments Paid volunteering and charitable donation/match programs Diversity Equity & Inclusion Initiatives including Employee Resource Groups Dedicated Training Resources and Learning & Development Programs Paid Educational Assistance *US Only **Center Valley, PA and Westborough, MA Are you ready to be a part of our team? Learn more about our benefit and incentives ( . The anticipated base pay range for this full-time position working at this location is $23.11 - $30.05 / hour, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications. At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit . Olympus is dedicated to building a diverse, inclusive and authentic workplace We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive. Let's realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Applicants with Disabilities: As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at . If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (). Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA)

Created: 2024-10-23