Katalyst CRO ยท 3 months ago
Medical Device Validation Engineer
Arden Hills, MN
Contract
Onsite
Entry, Mid Level
2+ years expKatalyst Healthcares & Life Sciences is a global team at Boston Scientific focused on overseeing a network of suppliers for finished medical devices. The Supplier Quality Engineer II is responsible for ensuring patient safety by improving supplier manufacturing processes and managing quality issues related to Single-Use Devices and Capital Equipment accessories.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
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
Qualification
Required
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%
Preferred
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
Company data provided by crunchbase