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QA Associate Documentation IBoston Scientific • Coventry, Colorado, United States
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QA Associate Documentation I

Boston Scientific
  • US
    Coventry, Colorado, United States
  • US
    Coventry, Colorado, United States
Jetzt Bewerben

Über

About the role: This role attracts 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. The position offers the opportunity to influence how documentation supports overall quality and operational excellence within the Coventry facility.
Work model, sponsorship, relocation: This is an onsite role based in Coventry. Boston Scientific will not offer sponsorship or relocation assistance for this position.
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.
Qualifications: 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.
Equal Employment Opportunity Statement: Boston Scientific Corporation has been and will continue to be an equal‑opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Safety‑Sensitive Position: Boston Scientific maintains specific prohibited substance test requirements for safety‑sensitive positions. This role is deemed safety‑sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
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  • Coventry, Colorado, United States

Sprachkenntnisse

  • English
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