Responsibilities
- Collaborate with stakeholders to identify business needs and define solutions, emphasizing simplification, standardization, and modernization.
- Represent business needs within the eQMS Complaints pillar, translating them into clear requirements and user stories with acceptance criteria.
- Lead and participate in design, build, testing, and deployment to ensure validated solutions are delivered.
- Support data conversion, master data setup, and integration of site processes.
- Build deep knowledge of site business processes, pain points, and opportunities to guide effective solution design.
- Develop train-the-trainer level eQMS expertise and support training plan development, materials, and delivery.
- Document and update procedures, partnering with teams to ensure readiness for deployment and post-launch support and maintenance.
- Collaborate with Solution Architects, Functional Analysts, SMEs, and vendors to design and deliver effective processes and systems.
- Drive harmonization, adoption of best practices, and continuous improvement across global processes.
- Provide guidance and feedback to team members while fostering inclusion and clear communication in cross-functional settings.
- Maintenance of existing platform through implementation of eQMS and ongoing maintenance and improvement of eQMS platform once implemented.
Requirements
- Bachelor’s degree and 5+ years relevant QMS experience in medical device or pharma (or master’s degree with 3+ years relevant QMS experience in medical device or pharma).
- Proven track record in continuous improvement methodologies (e.g., Lean, Six Sigma, or similar).
- Strong listening and communication skills, with the ability to transfer knowledge effectively.
- Demonstrated integrity, professionalism, and ability to establish credibility with stakeholders.
- Ability to operate with a high sense of urgency and commitment to execution.
Nice to Have
- Experience with complaint handling processes and systems.
- Prior project experience, with demonstrated adaptability and ability to perform effectively in fast-changing environments.
- Background in digital product ownership or IT project delivery, ideally in a regulated life sciences environment.
Benefits
- Core and optional employee benefits offered by Boston Scientific — see www.bscbenefitsconnect.com. Benefits vary based on actual location and other factors.
Work Arrangement
Hybrid
Additional Information
- The role is hybrid.
- It is unlawful to require or administer a lie detector test for employment in MA.
- Compensation for non-exempt (hourly), non-sales roles may 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).
- At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
