Recruiter: Spencer Gregory Hale
Senior QA AuditorAbout the role:This Senior QA Auditor role focuses on planning, executing, and documenting internal and external quality audits, with a strong emphasis on ISO 13485 compliance. The individual will lead audits end to end-developing audit plans, conducting on-site and system audits, writing clear and detailed audit reports and findings, and following through on corrective actions-while also supporting and managing external audits with regulatory bodies such as the FDA and notified bodies. The position requires deep knowledge of quality systems within the medical device or pharmaceutical industry, strong critical thinking and questioning skills to drive process improvement, excellent written and verbal communication, and the ability to work cross-functionally, collaborate effectively, and provide clear updates to management.
Your responsibilities will include:- Audit Planning & Execution - Develop and execute annual audit plans covering the landscape of the Quality Systems applicable to the division.
- Compliance Monitoring: Ensure adherence to internal policies, external standards, and regulations.
- Evaluate the adequacy and compliance of systems, operations, and practices against regulations and company documentation.
- Assess the effectiveness of internal controls, risk management systems, and identify vulnerabilities in the processes and sub-processes within the Quality Systems.
- Formulate and document nonconformities and obtain concurrence from responsible management.
- Track issues through to closure, including reviewing the corrective actions taken.
- Develop audit plans, including scope and objectives, and obtain management approval.
- Communicate the results of audits to responsible management through the appropriate channels.
- Prepare clear reports on findings, obtain approval, and publish results to the responsible management.
- Oversee the follow-up of corrective actions and audit closure, including escalating overdue items as necessary.
- Participate and support external investigators/auditors from regulatory authorities and notified bodies.
What we're looking for in you:Required Qualifications:
- Bachelor's degrees at a minimum.
- ISO 13485 Lead Auditor certification is required.
- Minimum of five (5) years of experience in the medical device or pharmaceutical industry, specifically within quality systems.
- Senior-level experience in quality auditing, with the ability to independently plan, execute, and close audits.
- Demonstrated experience conducting internal audits and supporting or managing external audits, including audits with regulatory bodies and notified bodies (e.g., FDA, TÜV).
- Strong working knowledge of quality systems and ISO 13485 requirements.
- Excellent written communication skills, with experience writing audit reports, findings, and documentation.
- Strong verbal communication and questioning skills, with the ability to critically assess processes and drive improvement.
- Proven ability to work cross-functionally, collaborate effectively with stakeholders, and provide updates to management.
Preferred qualifications:
- Previous Boston Scientific experience
- Proven project management experience
Requisition ID: 628992Minimum Salary: $ 89200 Maximum Salary: $ 169500 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.
