Medical Device Quality Engineer

Outcomes

The Senior QA Engineer spearheads engineering quality throughout every stage of product development. Engineering Quality encompasses the deployment and upkeep of the customer’s Quality Management System, ensuring product adherence to rigorous validation, verification, and implementation standards while fostering a culture of perpetual improvement, optimizing efficiency, minimizing defects, and elevating customer satisfaction.

Design Controls

The Senior Quality Engineer will establish and maintain design inputs, conduct risk assessments, perform design reviews, and document traceability of all CUSTOMER’S devices and software, ensuring that it meets the necessary performance and safety requirements throughout the design and development lifecycle.

·        Support CUSTOMER’S’ Design Control Management.

o   Support the design control process to ensure that CUSTOMER’S devices and software meets or exceeds quality standards,

o   leading to reliable and safe X-ray products.

o   Design and enforce design control processes to demonstrate compliance with regulatory requirements set forth by the FDA, ISO 13485, and IEC.

o   Generate meticulous documentation of design inputs, design outputs, verification and validation activities, providing evidence to demonstrate regulatory and customer compliance.

o   Execute systematic identification, assessment, and mitigation of potential risks associated with product design, reducing the chances of harm.

o   Establish a framework for traceability, ensuring that design decisions, changes, and verification/validation activities are documented, providing accountability and enabling effective post-market surveillance, maintenance, and continuous improvement efforts.

Design Transfer and Pre-Launch

The Senior Quality Engineer will facilitate smooth design transfer and product launch by conducting design reviews and risk analyses, monitoring process development and validation, controlling essential documentation and fostering cross-functional collaboration

·        Facilitate fast regulatory approvals and a smooth design transfer to manufacturing

o   Foster excellence in engineering quality and address emerging issues in advance to execute a seamless transition from design to manufacturing.

o   Create high-quality and robust engineering documentation and device records to facilitate swift regulatory approval.

o   Preemptively detect and rectify potential problems to reduce time to market.

o   Ensures all CUSTOMER’S products are reliable, safe, and effective devices to drive enhanced customer satisfaction and superior patient outcomes.

o   Cost Efficiency: Early detection and resolution of potential issues through quality engineering prevent costly recalls, reworks, and delays, promoting cost efficiency.

o   Bolster CUSTOMER’S’s brand reputation by promoting reliability and excellence and strengthening CUSTOMER’S’ position in the market.

Quality Management System Excellence

The Senior QA Engineer should promote adherence to the CUSTOMER’S Quality Management System throughout the organization. In addition, they should strive to refine and optimize the system to unlock the potential of the CUSTOMER’S Product Development Organization fully.

·        Maintain and promote adherence to CUSTOMER’S’ ISO 13485 & MSDAP Quality Management System.

o   Ensures all processes align with ISO 13485 standards, meticulously documenting and regularly updating both production and post-production activities.

o   Implement regular employee training and workshops to ingrain ISO 13485 requirements within the organization, and clarifying individual responsibilities within the QMS.

o   Conduct routine internal audits to check ISO 13485 compliance, and adeptly manage external audits by regulatory or certification bodies.

o   Execute the CAPA process, managing non-conformities by conducting root cause analyses, implementing corrective and preventive measures, and verifying their effectiveness

Competencies

An excellent candidate for this position will embody several competencies that management believes will lead to success. These competencies are:

·        Attention to detail

o   Attention to detail is crucial for a Senior Quality Engineer as it enables them to identify minor discrepancies or errors that could potentially lead to significant quality issues, regulatory non-compliance, or adverse effects on patient safety in the context of medical device manufacturing.

·        Intelligence

o   The Senior Quality Engineer must understand complex systems, solve challenging problems, and make informed decisions that uphold product quality and safety.

·        Efficiency

o   The Senior Quality Engineer must be able to optimize processes, reduce waste, meet tight deadlines, and contribute to the company's agile response to rapid changes and growth.

Technical Requirements

This position is a technical role on the Quality Assurance Team. The QA Team uses a suite of technologies and processes; the ideal candidate will be familiar with them. Proficiency levels in the following technologies, processes, and aspects are required for this role.

Technology

CUSTOMER’S Application

Proficiency¹

ISO 13485 &

Design Controls

Knowledge of ISO 13485, Design Controls (Phase 1-5), and other relevant standards are crucial for ensuring compliance and developing safe, effective products.

Expert

IEC 62304

Knowledge of Software Design Controls (SDS, SRS, SAD, Level of Concern) will be critical for this role as they lead product teams in documented design & compliance for products with complex software.

Advanced

ISO 14971,

dFMEA, and pFMEA

Understanding risk assessment tools and methodologies is necessary for identifying potential risks in product design or processes.

Advanced

CAPA and NCR investigations

Senior QA will play a crucial role in identifying, addressing, and preventing nonconformities, thereby ensuring product quality, safety, efficacy, regulatory compliance, and continuous improvement.

Advanced

Supplier Audit

Proficiency in conducting supplier audits to ensure compliance with quality standards and regulatory requirements. Familiarity with scoring methodologies.

Advanced

MDSAP