Supplier Quality Engineer

Supplier Quality Engineer

The Supplier Quality Engineer supports product development, manufacturing, process validation, risk management, design controls, and continuous improvement activities for medical devices in a highly regulated environment. This role works cross-functionally with R&D, Operations, Supplier Quality, Regulatory Affairs, and other functions to ensure products and manufacturing processes are developed, validated, and maintained in accordance with applicable quality system and regulatory requirements. The Supplier Quality Engineer applies engineering principles, risk-based thinking, statistical methods, and structured problem-solving techniques to support product and process quality throughout the product lifecycle, and independently executes assigned quality engineering activities while seeking technical guidance for highly complex or novel issues.

Responsibilities

• Support development and maintenance of product and process risk management documentation, including PFMEAs, hazard analyses, and associated risk assessments.
• Facilitate or participate in cross-functional PFMEA activities to identify potential failure modes, process risks, controls, and opportunities for risk reduction.
• Ensure identified risk controls are appropriately implemented and supported by objective evidence.
• Update risk management documentation in response to design changes, process changes, nonconformances, CAPAs, complaints, and other quality information.
• Support development and qualification of manufacturing processes for medical device products, with a focus on supplier and materials-related processes.
• Develop and execute process characterization and process validation activities, including IQ, OQ, and PQ, as applicable.
• Develop and execute test method validation activities to ensure reliable and repeatable measurement systems.
• Author and review validation protocols, reports, data summaries, and supporting documentation.
• Partner with Manufacturing and Engineering to establish appropriate process parameters, acceptance criteria, inspection requirements, and process controls.
• Support investigation and resolution of validation deviations and unexpected results using structured root cause analysis.
• Apply risk-based approaches to determine appropriate validation requirements and levels of testing.
• Support Design Control activities throughout product development and design changes, ensuring quality and manufacturability considerations are incorporated.
• Review design inputs, outputs, specifications, drawings, and other engineering documentation for completeness, clarity, testability, and manufacturability.
• Support identification and flow-down of critical-to-quality (CTQ) attributes into manufacturing specifications and process controls.
• Participate in design reviews and provide Quality Engineering input to cross-functional teams.
• Support Design Transfer activities to ensure product and process requirements are appropriately transferred into manufacturing.
• Verify that appropriate manufacturing specifications, procedures, inspection methods, acceptance criteria, and process controls are established prior to transfer.
• Support planning and execution of design verification and design validation activities.
• Review and contribute to verification and validation protocols, test methods, acceptance criteria, sample-size rationale, data summaries, and reports.
• Ensure verification and validation activities are appropriately traceable to applicable requirements and risk controls.
• Support investigation and documentation of deviations, anomalies, and unexpected test results.
• Apply appropriate statistical methods to support process development, validation, verification, and quality improvement activities.
• Perform and interpret statistical analyses such as descriptive statistics, confidence intervals, capability analysis, GR&R, and other applicable methods.
• Support development and execution of Design of Experiments (DOE) and other advanced statistical analyses as appropriate.
• Use data to identify trends, evaluate process performance, and support engineering and supplier-related decisions.
• Ensure assigned activities comply with internal procedures…