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Lead Supplier Quality Engineer
3 months ago
Location: Canada-ON-Ottawa
Core Values: Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we empower you to leverage your full potential by collaborating with a diverse and high-achieving workforce, addressing critical challenges in the healthcare sector. With access to cutting-edge tools, resources, and training, we are committed to supporting your professional growth and aspirations.
Position Overview
The Senior Supplier Engineer acts as a technical authority for the TheraSphere team, overseeing and managing all facets of projects and initiatives aimed at enhancing processes and materials initiated by Boston Scientific or its Contract Manufacturing (CM) partners. This role requires independent management and guidance on projects for integrating new service providers, collaborating with cross-functional teams to fulfill deliverables aligned with business objectives for the TheraSphere product line. The Supplier Engineering Team is tasked with providing technical leadership and resolving non-conformances and process enhancements to ensure business continuity and the seamless integration of product and process modifications at CM sites in accordance with Boston Scientific standards. The Senior Supplier Engineer plays a crucial role in driving performance improvements among Sourced Finished Medical Device (SFMD) suppliers to consistently meet Boston Scientific's stringent requirements. This position necessitates a strong commitment to patient safety and effective collaboration with suppliers and cross-functional teams to guarantee that product quality aligns with customer expectations.
Key Responsibilities:
- Lead projects and initiatives with suppliers to pinpoint areas for enhancement and offer guidance for process improvements.
- Assess and initiate projects related to mass escalation and reactor capacity to ensure manufacturing capabilities are established to meet future product demands.
- Encourage open and transparent communication with suppliers to ensure a mutual understanding of expectations and objectives, leveraging six sigma and lean manufacturing methodologies for large-scale process improvement initiatives.
- Collaborate and communicate with cross-functional teams, including Quality Assurance, Manufacturing, and Regulatory, to align supplier performance with corporate goals.
- Oversee the execution of SFMD Engineering and Quality deliverables while collaborating with cross-functional new product development teams for the next generation of the device.
- Engage with suppliers to assist in the investigation of material issues or supply constraints.
- Investigate and resolve supplier-related challenges, such as non-conformances, quality discrepancies, and delivery delays, promptly and effectively.
- Conduct and support NCEP/CAPA investigations to identify and address root causes for process deviations and component modifications.
- Assist in product complaint investigations where supplied materials may be a contributing factor, utilizing basic statistical tools as necessary.
- Ensure compliance with the Quality Policy and all documented quality processes and procedures to uphold Boston Scientific's commitment to patient safety and product quality.
Required Qualifications:
- Bachelor's degree in engineering, preferably in Biomedical Engineering.
- Experience in a regulated environment adhering to ISO13485 and FDA guidelines.
- 7+ years of relevant experience as a Supplier/Sustaining Engineer.
- Proficiency in statistical tools, such as Minitab.
- Strong report writing skills.
- Solid understanding of statistical methods, problem-solving techniques, and six sigma methodologies.
Preferred Qualifications:
- Effective communication skills at all levels, with strong technical writing and reporting capabilities.
- Organized and detail-oriented, with the ability to prioritize and manage multiple projects.
- Strong interpersonal skills to develop relationships internally and externally.
- Results-oriented with robust critical thinking and analytical abilities.
- Experience in nuclear medicine and handling radioactive materials.
- Experience leading projects with suppliers and/or contract manufacturers.
Requisition ID: 583213
Boston Scientific has been a leader in medical science for over 40 years, dedicated to addressing the most significant challenges in healthcare. Our mission to advance science for life focuses on transforming lives through innovative medical solutions that enhance patient outcomes, create value for our customers, and support our employees and the communities we serve. We believe in the importance of nurturing a diverse and inclusive workplace, which fosters innovation and reflects the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.
