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QA Document Control Associate II Job

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Company :
Boston Scientific

Location :
Cambridge, Massachusetts

Expiry Date :
Fri, 05 Feb 2021 23:59:59 GMT

Apply Job :
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Description :
Additional Locations: Purpose and Passion * Comprehensive Benefits * Life-Work Integration * Community * Career Growth At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose-improving lives through your life’s work. Quality Assurance Documentation and DQA Associate II–Cambridge About this role: In this critical role at the Cambridge site, you will have primary responsibility for the site’s Document Control activities while also benefiting from personal and professional growth in Design Quality Assurance, Quality Systems, and Medical Device resulting from collaboration with site, divisional and corporate partners. Your responsibilities include: – As Document Control representative in Cambridge, support all document control activities in Cambridge including preparing new and revised documents for routing per the local document approval process. Tracks progress in obtaining approvals for document change notices to aid in timely approvals. – Incorporates documentation edits and updates all logs associated with documentation status. Releases approved documents and notifies affected personnel of changes impacting functional areas. – Recommends changes to processes documentation and training programs in the spirit of continuous improvement. – Interfaces with teams in implementation of quality systems upgrades. – Manages the biennial review of documentation system to ensure compliance to standards. – Supports internal, regulatory, notified body and corporate audits. – Interacts between functional groups in support of Document Change Notices. – Facilitates Document Review meeting and makes recommendations as needed to functional areas. – Opportunity to support quality related needs of various departments including Quality Systems, Design Quality Assurance, and R & D. This may include generating validation documentation, executing installation process instructions, owning non-conformances and/or CAPAs, creating quality management review documentation and providing quality planning support. – Help maintain various spreadsheets and databases for quality systems processes. – Update supervisor of work status or problems with recommendations for improvement or correction. What we’re looking for in you: – 4 year college degree – Work experience in related discipline or area – Ability to work in a fast paced, dynamic environment – Demonstrated competence working with different software applications and systems (such as SAP, SASS, WorkFront, SalesForce, etc) – Team player – High energy problem solver capable of driving items to closure – High attention to detail – Excellent communication skills Preferred Qualifications: – Document Control experience – Experience with computerized Document Control systems such as Windchill, MasterControl, or similar – 2+ years of Medical Device experience About us As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen. Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code * 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination. Requisition ID: