Recruiter: Spencer Gregory Hale
Principal Quality Analysis - CAPA MentorAbout the role:This role provides site-level CAPA mentorship, oversight, and approval support across the quality system. The CAPA Mentor partners with CAPA owners, project teams, and Quality leadership to ensure timely, compliant, and effective corrective and preventive actions, while driving continuous improvement and risk reduction.
Your responsibilities will include:Key responsibilities include, but are not limited to, the following:
- Manage and oversee the CAPA portfolio, including monitoring, tracking, and reporting CAPA health, compliance, and performance metrics to Quality leadership.
- Serve as a CAPA Mentor by coaching and guiding cross-functional teams through nonconforming events and the development, implementation, and verification of corrective and preventive actions.
- Provide subject-matter expertise on structured problem-solving methodologies and effective execution of the CAPA process across all phases.
- Partner with CAPA owners to ensure CAPA records are compliant with global and local procedures, clearly written, logically structured, and aligned with the intent of each CAPA activity, including appropriate documentation of rationale and decision-making.
- Collaborate with Quality Assurance, Project Management, and functional leaders to identify systemic quality issues and drive continuous improvement initiatives.
- Provide CAPA status updates, milestone tracking, and risk assessments to Project Managers and stakeholders for assigned projects.
- Review and approve CAPA records and phases, as applicable, ensuring compliance with global CAPA requirements and quality system expectations.
- Participate in Community of Practice meetings for nonconforming events and CAPA as needed.
- Participate in projects as needed.
What we are looking for in you:Minimum Qualifications:
- Bachelor's degree required.
- Minimum of 7 years of experience supporting nonconforming events and CAPA within a regulated environment.
- Experience working in regulated industries (e.g., FDA, ISO standards, EU MDR, ISO 13485).
- Demonstrated experience leading or mentoring cross-functional teams through nonconforming events and CAPA implementation.
- Strong written and verbal communication skills with a high level of attention to detail.
- Proven problem-solving, organizational, and execution skills.
Preferred Qualifications:
- Broad working knowledge of quality systems and processes (e.g., CAPA, NCRs, audits, complaints).
- Quality-related certifications (e.g., ISO 13485, AS9100).
- Subject-matter expertise in CAPA regulations and nonconforming event management.
Requisition ID: 632335Minimum Salary: $ 106800 Maximum Salary: $ 202900 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.
