Overview
Senior Quality Engineer I - Software is the emerging Subject Matter Expert that is accountable to participate on project teams and manage Quality function deliverables, and has responsibilities in one or more of the following areas:
Serves as a Quality representative on one or more project teams engaged in new product development, manufacturing transfer or other special projects
Responsible for assuring that each project is developed and released meeting customer expectations, regulatory requirements including 21CFR820, 21CFR11,ISO 13485, ISO 14971, IEC 62304, IVDD 98/79/EEC, and/or EU Medical Device Regulation (MDR) 2017/745
Responsible for leading/guiding computer system validation activities and 21CFR11 applicability and compliance assessments
Responsible for development planning, design input, design output, design history file management, design transfer, change management, risk management and design reviews for application and embedded software
Reviews and approves product documentation, drawings, process and design verification/validation
Applies statistical tools to analyze data and identify root cause and problem resolution
Main Responsibilities
This position will work with new or transferred products to administer the design control and validation elements of the Quality System to ensure regulatory compliance and robust product/process design for new software products and maintenance of existing software products. The position is accountable for the applications of industry standard quality practices and tools to the Instrument Plant and it's suppliers. The position requires the ability to lead multiple projects and tasks utilizing a high level of project management, written and oral communication skills. Will apply software knowledge, reasoning and judgment skills to ensure the appropriate balance of quality, compliance and business needs.
Cost Center Specific:
* Develop, enhance and maintain strategies and plans to enhance the overall quality of software including test coverage, and system performance.
* Provides strategic and tactical support of Quality Engineering Function, based on understanding of 21 CFR Part 820 and ISO Requirements.
* Owns and facilitates the Design Review and Functional Review Process for software products.
* Collaborates with Manufacturing and R&D to support software products for design improvements, and monitor measurable improvements. Routinely interacts with multifunctional groups.
* Ensures BD PI Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies.
* Represent the Quality Function for New Product Development Core Teams and/or Technology Transfer Core Team
* Serves as core team member on software development projects, to include completion of assigned deliverables (requirements, SW development planning, risk management, V&V, etc).
* Remediates software related audit findings and CAPAs.
Qualifications
Knowledge/Skills
:
* Ability and skill to effectively manage multiple tasks and lead execution of change management plans
* Ability and skill to manage the Quality function for design projects, reliability concepts for complex systems, validation planning and statistical sampling, six sigma root cause analysis tools and project management techniques
* Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
* Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations
* Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems
* Ability and skill to analyze using systematic analysis tools that include root cause, failure analysis and risk assessment to gather critical information and diagnose
* Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution
* Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO).
Education
:
Bachelor's degree in Electrical, Mechanical, Software or Biomedical Engineering or other relevant technical area with 6 to 7 years of experience, where 4 of those years are progressive experience in software development or lifecycle management. Or MS/MBA with 7 years of experience, where 5 of those years are progressive experience in software development or lifecycle management.
Additional Qualifications/Experience
* Capacity to work with Product Lifecycle Mangement system such as Agile / Documentum or Information system such as TrackWise or Learning Management System such as C2C
* Experience with quality tools and process improvement techniques
* Demonstrated problem solving experience
* Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
* Good communication skills
* Fluent in English