Senior Specialist, Design Assurance

Roles & Responsibilities

Key Job Purpose:

The Design Assurance Senior Specialist is responsible to provide focused quality engineering support with new product development, sustaining engineering and post-market activities. The incumbent is to ensure the organization (as Product Owner) adheres to all regulatory and quality standards by effectively managing critical quality systems, including Design Control, Complaint Handling, Post-Marketing Surveillance and Supplier Management. The role serves to maintain a high standard of compliance, accuracy, and continuous improvement throughout the organization's quality processes.

The incumbent will also drive improvement and corrective action in the quality of products/components and services outsourced from external suppliers. This role shall provide technical support in the selection of suppliers, particular outsourced software developer; help to develop and recommend acceptance criteria and monitor supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

Job Descriptions

• Cross-Functional Collaboration: Work closely with a cross-functional team (Project Manager, Contract Manufacturer/Supplier, Regulatory Affairs, Marketing, Quality Management team etc.) to provide input on project decisions with a quality-first mindset.
• Design Control: Execute design controls deliverables for Medical Devices such as Software as Medical Device or Medical device with embedded software. Develop the design control framework in organization QMS structure and provide feedback on Design Inputs, Outputs, Verification and Validation protocols and reports, Risk Analysis (Hazard Analysis, DFMEA), Usability, Cybersecurity, Manufacturing/Supplier related activities. Lead the development of and coordinate the execution and documentation of Design Validation and Verification activities.
• Risk Management: Maintain product Risk Management Files (per ISO14971 requirements), Design History Files, Design Master File. Develop and implement quality assurance processes, methodologies, standards to ensure software products meet the required quality, safety and performance requirements.
• Complaint Management & Post Market Activities: Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving product quality issues. Track and monitor the customer complaint from the complainant and work with the relevant manufacturing sites or contracted developers/critical suppliers for the investigation and closure of the complaint. Drive investigation and solution implementation for CAPAs, jointly with contract software developer and/or critical suppliers. Analyze complaint data to support ongoing monitoring of device safety and performance.
• Product Lifecycle: Mentor cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables.
• Supplier Management: Assess suppliers for technical, quality and manufacturing capabilities. Perform assessment of supplier capabilities through desktop assessment, direct on-site visits, and technical discussions and follow-up actions based on results of Supplier Quality System Audits.
• Audit Support (Internal and external): Assist in the planning, execution, and follow-up of internal audits, ensuring compliance with regulatory standards and company policies. Support external audits by coordinating audit activities, preparing documentation, and ensuring audit readiness pertaining to Design Control and Supplier Management perspective. Ensure that audit findings are addressed through effective corrective actions and continuous improvement. Also act as an audit member for regional audit, if requested by management.

Job Requirements

• Minimum of a Bachelor's Degree in Biomedical Engineering, Software Engineering, Electrical Engineering, or related engineering discipline.
• Minimum 5 years experience in Design Assurance, new product development or related medical device experience
• Experience with medical device SOFTWARE and/or HARDWARE development and validation
• ISO 13485, ISO 14971, and fundamental understanding of MDD or IVR Regulations understanding with a focus on Design Controls and Risk Analysis.
• ISO 13485: 2016 QMS
• ISO 14971: 2019 Risk Management
• ISO 27001: 2022 ISMS
• Good understanding of software development methodologies, testing framework and quality assurance tools.
• Knowledge of and keeps abreast of medical device cybersecurity requirements.
• Knowledge in managing contract manufacturer or design contractor for software as medical device.
• Demonstrate ability to manage and complete multiple projects and objectives and lead cross-functional teams
• Strong track record of leading and influencing across functional groups, leadership levels and regions
• Ability to work in a fast paced, dynamic environment

Tell employers what skills you have

Supplier Performance
Embedded Software
Supplier Quality
Quality Management
Quality System
Regulatory Affairs
Job Descriptions
Risk Management
ISO 27001
DFMEA
Biomedical Engineering
Quality Engineering
Engineering Support
Design Control
Hazard Analysis
Audit

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