Design Quality Engineer

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(targeted dates March 6th-June 16, 2023). Contractor will be responsible for providing their own equipment (ie: laptop) during engagement. Position will be remote but required to work Eastern Hours.

Project Description

Provide Quality Assurance / Engineering support to software product development, IT Implementation, and process improvement projects in Digital Solutions. Regularly interface with project team members of product development, clinical operations, regulatory, V&V, IT, PMO, and other stakeholders to ensure that the Design control, IT Systems Software V&V, and Quality Management & Compliance processes are followed.

Years Of Experience

Overall 3-5 years relevant experience in IT & Quality in a regulated medical devices realm

2-3 years in software management or other IT environments subject to FDA or other government regulations.

2-3 years of hands-on experience in software validation and managing validation strategies

1+ years of experience working in Quality / Regulatory / Compliance. Exposure to risk-based compliance.

1+ years of experience working in agile development methodology.**

Education Required

BS or BA in quality / computer science / applied sciences or equivalent

Knowledge of FDA regulations (21 CFR 820, cGxP, 21 CFR Part 11), EU MDR, ISO standards (9001, 13485, 14971, 27001), IEC 62304, HIPAA, GDPR etc. Preferable Certification in Auditing or knowledge in the above.

Preferable - Certifications in Quality (ex CSQE, CQM etc.)

Preferable Certifications in project, change, and/or process management (Lean, Six Sigma, PMP, CMMi etc.)

Detailed Responsibilities Include

Quality Assurancing:

Execute quality assurancing and process management related activities in the development of new digital products and software management processes. Represent the mindset and principles of the Quality department and drive quality initiatives. Assure adherence to quality systems in order to achieve highest levels of compliance.

Work in project and product teams in the medical device realm and execute activities like product risk management, privacy & information security risk management, process compliance monitoring, supplier quality management, change management.

Utilize effective and efficient Quality Engineering techniques such as risk analysis, test method development, design of experiments, statistical data analysis, and development of sampling plans throughout the product lifecycle to execute associated tasks in Quality Engineering

Ensure product lifecycle deliverables meet the requirements of LifeScans processes, regulatory reviews, and pass internal and external audits. Ensure audit follow-ups and findings are appropriately addressed promptly.

Quality Stewardship

Lead activities within the quality system such as: change control, validation, design control, NC, CAPA, and risk management activities. Drive the organization to on-time closure of such records with highest quality.

IT Systems V&V Process

Execute IT Systems validation programs and ensure the adherence to LifeScan validation processes and methodologies and medical devices industry best practices. Work with stakeholders and suppliers to ensure high quality and on-time commissioning of IT systems. Identify and implement ways to make the processes efficient while ensuring compliance.

Soft Skills

Capable of working both, as a team member, and independently, in translating a given strategy into tactics and measures.

Capable of managing complexity in projects, multi-tasking, and engaging in cross functional global projects. Capable of solutioning and not getting mired down by obstacles.

Capable of clear communication and have the aptitude to listen to understand.

Negotiate with and influence business partners & suppliers to ensure product quality and compliance to quality systems

Makes decisions based upon data. Understands the balance of day-to-day activities versus big picture. Can assess risk and act/escalate appropriately.

Innovation

Identifying and improving problem solving and fault diagnosis processes within the engineering teams

Identifying opportunities and implementing projects to continuously improve quality, cost, and time factors in our quality systems, processes, operations, and tools.