QA Associate Documentation IBoston Scientific Gruppe • Coventry, Colorado, United States
QA Associate Documentation I
Boston Scientific Gruppe
- Coventry, Colorado, United States
- Coventry, Colorado, United States
Über
About the role 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.
Work model, sponsorship, relocation 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.
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.
Requisition ID: 629260
Minimum Salary: $47,200
Maximum Salary: $89,700
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com – 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. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non‑exempt (hourly), non‑sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non‑sales roles may also include variable compensation, i.e., annual bonus target and long‑term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
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.
Please be advised that certain U.S. based positions, including, but not limited to, field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID‑19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID‑19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID‑19 vaccination.
Among other requirements, 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.
Nearest Major Market: Providence
Nearest Secondary Market: Rhode Island
Job Segment: Compliance, Technical Writer, Quality Assurance, QA, Document Control, Legal, Technology, Quality, Administrative
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Sprachkenntnisse
- English
Hinweis für Nutzer
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