Senior R&D Engineer – CAPA Specialist responsible for leading complex CAPA investigations within the Research & Development organization.
Compensation
Salary range: $115k - $140k; 10% STIP
Responsibilities
Lead and execute product design and or Design Controls process related CAPA investigations within the R&D organization, from problem definition through implementation and effectiveness verification.
Perform thorough and structured root cause analyses for design, verification, validation, and product performance issues using appropriate analytical tools and data.
Develop and drive robust corrective and preventive actions that are risk-based, technically sound, and aligned with design controls and risk management processes.
Ensure CAPA documentation is accurate, complete, and compliant with FDA regulations, ISO 13485, and internal quality system requirements.
Collaborate closely with cross-functional partners—including Quality, Regulatory Affairs, Operations, and Manufacturing Engineering—to address systemic and cross-functional issues.
Requirements
Bachelor's degree in Engineering or related technical discipline; advanced degree preferred.
Guides implementation of comprehensive process validation plans and ensures design control processes for new products to production, managing quality engineering documents and leading quality improvement projects.
Responsibilities
Guides implementation of comprehensive process validation plans using statistical tools
Ensures smooth execution of the design control process
Reviews and assesses detailed quality engineering documents
Proposes and initiates multiple quality improvement projects
Facilitates technical and QMS capability assessments of potential new suppliers, ensuring they meet the company's quality standards, and contributes to the supplier selection.
Conducts & reviews DFMAT, SRPQP, MSA, PFMEA, Control Plan, SPC, PV&V, FAI, LRA, and SICR.
Develops, executes, monitors, and controls APQP plans as part of the NPI and LCM process to ensure consistent product quality.
Contributes to the content of the Supplier Project Book, documenting detailed quality requirements and expectations for suppliers.
Facilitates collaboration between R&D and suppliers in Design for Excellence initiatives to enhance product design quality and innovation.
Requirements
Bachelor's/ Master's Degree in Engineering Science, Supply Chain Management, Electrical Engineering, Electronic Engineering or equivalent.
The base salary range for this role is €[Min]–€[Max]. We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you'll have in this role, alongside internal equity and local market considerations. This role is eligible for [bonus/incentive], with your rewards linked to [KPIs/company results]. We’ll share the full approach with you during the interview process, so you can make a clear, informed decision. Benefits include [key benefits].
Responsibilities
Guides the implementation of comprehensive process validation plans using statistical tools to ensure effective transition of new products to production
Ensures the smooth execution of the design control process, from eliciting and validating design inputs to managing verification, validation, and design transfer
Reviews and assesses the detailed quality engineering documents, including quality plans for hardware, software, and system design
Proposes and initiates multiple quality improvement projects, integrating quality, reliability, and Post Market Surveillance plans
Reviews and constantly evaluates product and system designs, guides the analysis of performance data, and performs root cause analysis
Analyzes defects for determining dispositions of non-conformances and drives management of Non-Conformances (NC) and Quality Notifications (QN) and implements effective Corrective and Preventive Actions (CAPA) actions.
Helps to conduct the assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities.
Supports operations performance monitoring, risk assessment, reporting, improvement and development, aids with improvement programs in factory, and supports analytical testing and Supplier Quality Engineering (SQE), Supplier Quality Assurance (SQA) and Purchasing.
Coordinates timely quality engineering and quality assurance tasks, aids in ensuring manufacturing quality systems are maintained, and helps in completion of New Product Introduction (NPI) and product transfers in factory.
Possesses working knowledge of generic products/services and Quality Engineering and Continuous Improvement techniques, exercises judgment within defined procedures and policies to determine appropriate action, and frequently interacts with supervisors and functional peer groups to gain cooperation of others.
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