Sr. QA Software Engineer
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Position Reports To: Designated Supervisor or Manager
Position Directly Supervises: No one
Job division: Regulatory Affairs
Over-Time Status: Exempt
Purpose Of Position: Responsible for leading and maintaining the ongoing regulations and compliance processes of the Company’s medical software(s).
To fulfill this position successfully, an individual must be able to perform each essential function satisfactorily.
- Please check L (Still Learning Function), P (Successfully Performing), NP (Not Performing) or N/A (Not Applicable) for each as appropriate. Note comment # on page 2c.
- CollLeads the ongoing implementation of Software Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medical device industry best practices. Is the key administrator for the QMS software.
- Collaborates with software development teams in the creation of Design History Files (DHFs) including software development plans, software verification and validation plans, software requirements specifications, software architecture and design documents, design and code reviews, software Risk Management File (RMF), test protocols and reports, traceability matrices.
- Integrates ISO 14971, risk management and IEC 62366 usability engineering activities with Glidewell/Prismatik processes.
- Mentors and provides direction to software development teams in design controls and lead risk management activities.
- Fosters and maintains organizational compliance to the quality system including ongoing training and education on software QMS and Prismatik framework.
- Provides CAPA, complaints, audit and overall QMS support in regards to software.
- Conducts investigations and provides corrective and preventive actions based on analysis and review. Provides and implements effective solutions that will drive continuous and measurable improvements.
- Performs other related duties and projects as business needs require at direction of management.
- The preceding functions have been provided as examples of the type of work performed by employees assigned to this job classification. Management reserves the right to add, subtract, or change the job functions
Minimum Qualifications: The requirements listed below are representative of the knowledge, skill, and ability necessary to successfully perform the essential functions of the position.
- Education and Experience:
- Bachelor’s degree in Computer Science, Software Engineering, Informatics, Biomedical, or related technical field or equivalent practical experience.
- Minimum of eight (8) years of experience in software design assurance in the FDA QSR/ISO 13485 medical device industry.
- Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk management) and IEC 62366 Usability Engineering.
- Experience with Agile software development methodologies like Scrum and Kanban.
- Experience with other than embedded software development areas, such as web development.
- Previous experience with digital health, Health IT or mobile medical applications required.
- Previous experience with cloud-based software preferred.
- Communication Skills:
- Knowledge, Skills, and Abilities:
- Must possess proficient English skills, both written and verbal.
- Must have strong written skills to convey complex technical concepts in concise written form.
- Must be able to read and understand all operating procedures and applicable technical information.
- Ability to explain solutions to technical problems and utilization of new technologies.
- Ability to create and compose written materials with proper English grammar and punctuation.
- Must possess effective oral communication and interpersonal skills with ability to deal with all levels of personnel in a professional and effective manner.
- Ability to read, interpret, and communicate the contextual meaning of numerical data.
- Ability to communicate effectively in a multi-cultural business environment.
- Advance knowledge with development and test requirements with recognized standards (ISO 13485).
- Demonstrated knowledge of the application of regulatory requirements for wellness, low-risk and high-risk software applications using a scalable approach to the Prismatik practices and the QMS.
- Demonstrated knowledge and understanding of software development, including cloud computing.
- Demonstrated ability to implement and improve Software QMS processes.
- Demonstrate knowledge of group software development methods (Agile Process and Scrum Method).
- Demonstrated knowledge of AWS architecture and tools (EC2, Lambda, RDS, Dynamo DB, RedShift, SQS, S3, API Gateway, Kinesis, and CloudWatch).
- Knowledge of CAD/CAM and AI/ML a plus.
- Demonstrated time-management skills to complete assignments while meeting critical deadlines.
- Ability to contribute effectively as a member of a team and work cohesively as a part of a team.
- Possess a strong attention to detail and accuracy.
- Proficient knowledge of general office procedures and office machines.
- Ability to effectively prioritize duties and efficiently complete responsibilities.
- Ability to work beyond normal business hours to meet critical deadlines and resolve emergency issues.
- Ability to travel within company premises occasionally, both domestically and internationally, depending on project requirements.
Physical Demands: The physical demands listed below are representative of those that must be met by an employee to successfully perform the essential functions of this position.
§ Ability to frequently bend and/or twist at waist/knees/neck to and from seated position while working at desk/bench and reaching for equipment.
§ Ability to frequently use standard office equipment such as but not limited to computers, telephones, copiers, and scanners.
§ Ability to constantly communicate with others.
§ Ability to maintain long periods of mental alertness and attention to detail while setting priorities, meeting critical deadlines, and following up on assignments.
§ Ability to constantly perform sedentary work, spending extended periods of time at desk or workstation.
§ Ability to seldom stand and/or walk for extended periods of time.
§ Ability to seldom climb stairs at some locations.
§ Ability to seldom push and/or pull up to five (5) pounds.
§ Ability to seldom lift or carry up to five (5) pounds.
§ Ability to keyboard for extended periods of time.
§ Ability to function in an environment with frequent interruptions.
§ Ability to deliver quality results under high pressure deadlines in a fast-paced environment.
§ Ability to demonstrate normal manual dexterity and eye-hand coordination; maintain corrected hearing and vision to normal range.
- Ability to travel to locations away from primary work place.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this position.
- Primarily an office setting environment with moderate noise levels and no direct exposure to hazardous physical substances.