What are the responsibilities and job description for the Medical Device Validation Engineer position at Katalyst CRO?
Job Description
The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Engineer II will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier's manufacturing processes. In this role, you will support SFMD products within the Relevant acquisition in the Neuromodulation division with a primary focus on Single-Use Devices and Capital Equipment accessories.
Responsibilities
Sustaining Engineering:
The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Engineer II will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier's manufacturing processes. In this role, you will support SFMD products within the Relevant acquisition in the Neuromodulation division with a primary focus on Single-Use Devices and Capital Equipment accessories.
Responsibilities
Sustaining Engineering:
- Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
- Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.
- Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
- Manages sustaining quality issues, process change impacts, and design change implementations for suppliers within the Relevant Quality system, the hybridized BSC-Relevant Quality System, and in the BSC Quality System after products are successfully integrated.
- Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centre's.
- Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.
- Investigates complaints and manages NCEPs at OEM suppliers and CM suppliers where the issue is manufacturing-related.
- Supports Supplier Change Impact Assessments for process changes at suppliers.
- Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.
- Supports projects and contributes to consistently hitting project milestones. Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process.
- Execute SFMD Plan deliverables for integration of acquired company's suppliers and products into BSC's Quality System.
- Support the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.
- Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.
- Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.
- Identifies and advises management on potential improvements to quality systems and processes in the company.
- Champions 100% compliance to company policies and SOPs.
- BS degree in engineering or technical field with minimum of 2 years of relevant experience.
- Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
- Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.
- Experience in process validation, design controls, risk management, CAPA, SCAR.
- Organized and self-driven.
- Articulate communicator adept at packaging and appropriately scaling information to the intended audience.
- Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
- Domestic and international travel up to 25%.
- 3 years of medical device engineering experience preferred.
- Medical Device Industry experience.
- Problem Solving and Project Management experience.
- Leadership experience on a materials or service commodity team.
- Lead auditor of quality systems experience (ISO 13485 or similar).
- ASQ certification (CQE, CBA, SSGB, SSBB) desired.