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QA Associate Documentation IIntracept by Boston Scientific • United States
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QA Associate Documentation I

Intracept by Boston Scientific
  • US
    United States
  • US
    United States
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Über

Quality Documentation And Compliance Specialist
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions. This role would attract someone who enjoys being at the center of quality documentation and compliance, ensuring every product meets strict internal and regulatory standards. It makes a strong impact by safeguarding product safety, maintaining accurate and audit-ready records, and supporting engineers and site teams to keep processes consistent and reliable. It also offers the opportunity to influence how documentation supports overall quality and operational excellence within the Coventry facility. This position is an onsite role based in Coventry. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time. Your responsibilities will include: Perform the review and approval of sterilization batch records to ensure all processing parameters are met according to Boston Scientific specifications. Assist in maintaining Boston Scientific policies and procedures related to sterilization and batch approvals. Coordinate the review and revision of documentation submitted through change requests in accordance with internal and regulatory policies and procedures. Copy, distribute and maintain documents in accordance with company procedures. Review final versions of documentation changes for potential issues and collaborate with staff to resolve discrepancies. Store and maintain all quality records, policies and procedures required for compliance according to internal policies and procedures. Support the Change Notice (CN) process through various stages, including CN creation, submission review, implementation and document issuance. Manage the distribution of documents as required throughout the change management process. Assist in gathering change metrics and preparing reports as required. Represent the site and participate in Global Community of Practice groups and associated projects as required. Process site nonconformance activities for the Documents and Records subprocess. Interpret and implement corporate documentation requirements as they relate to local documentation processes. Provide documentation and change management support as required. Partner with engineers to determine work instruction accuracy and technical writing documentation requirements. Required qualifications: Minimum of 2 years' experience reviewing and approving batch records, managing documentation changes, and maintaining quality records in a regulated environment. Minimum of 2 years' experience supporting documentation control, change management and compliance activities within a manufacturing, quality or regulated industry environment. Equivalent of 5 years of hands-on experience in documentation control, quality records management or regulated manufacturing processes in lieu of a degree. Approximately 4 years of directly related experience would replace the degree requirement. Demonstrated experience working with documentation control systems, batch record review processes and change management workflows. Demonstrated ability to adapt to frequent documentation updates, evolving procedures and changes in regulatory or internal requirements. Proven knowledge of compliance requirements related to document control, quality records and regulated manufacturing environments. Ability to manage multiple documentation workflows while maintaining accuracy and attention to detail. Strong technical writing and document review experience supporting engineers and cross-functional teams. Ability to work onsite in Coventry on a full-time basis. Preferred qualifications: Bachelor's degree in Engineering, Quality or a related field preferred. Experience working in a regulated medical device environment, particularly in documentation control, sterilization processes or quality systems. Preferred experience with electronic document management systems, change control platforms, Windchill, PDF tools, Excel and batch record review systems to support immediate productivity. Proven ability to adapt to frequent procedural updates, manage multiple documentation workflows and collaborate effectively with cross-functional teams. The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
  • United States

Sprachkenntnisse

  • English
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