Sr. Quality Systems Specialist

2 weeks ago

Eden Prairie, United States ACIST Medical Systems Full time
Job Description

Position Summary:

The Sr. Quality Systems Specialist - Software supports the validation, implementation, and maintenance of Bracco Medical Technologies internal Quality System software. This role will be responsible for owning and maintaining processes to appropriately control and validate Quality System software applications, oversee and manage validation activities and documentation for all QMS applications. As a system analyst this role will analyze, develop, and maintain certain QMS applications and implement configuration changes and improvements.

Primary Duties & Responsibilities:

Quality System Software Validation

•Implement and maintain processes and procedures to ensure that all QMS software is constructed and validated according to the appropriate regulations and guidelines, including 21 CFR Part 11.

•Manage all aspects of validation for QMS software that is managed internally, including Master Validation Plan, requirements, risk assessment, IQ/OQ/PQ protocols and reports, configuration and traceability documentation, and associated validation project management. Scale validation activities according to risks.

•Manage changes to QMS software applications, including use of change control tool, change impact analysis, procedures and associated documentation.

•Provide ACIST Quality support and approvals for implementation and changes to applications that are managed by Bracco corporate (e.g. SAP and TrackWise).

•Maintain an inventory of QMS software applications and validation status, in conjunction with IT and other departments. Review and update at specified intervals lead activities required to maintain compliance.

•Provide guidance, support, and approvals for validation and control of spreadsheets and electronic forms.

•Support the assessment and management of vendors and outsourced services related to QMS software applications and associated validation.

•As subject matter expert for QMS software validation, maintain current knowledge of regulatory environment, standards, guidance and regulations.

•Provide guidance and training to staff regarding software validation

QMS Application Analyst

•Analyze, develop, support, and maintain Agile PLM system and other applications/databases as necessary.

•Support the configuration and implementation of additional modules of the Agile PLM system, new QMS applications, and changes to existing applications.

•Work with various business teams to gather requirements, design, develop and document QMS applications/databases in order to support business processes.

•Develop user documentation and provide training to end users of QMS applications.

•Project management of system implementations, modifications and enhancements.

•Seek development activities to enhance technical expertise with Agile PLM and other applications.

•Manage user access requests and approvals for quality system software

Other Software Support

•Provide software QA support to development teams for product software

•Support verification and validation of product and test system software

•Support software risk assessment and associated documentation and provide guidance on appropriate scaling of validation activities

•Analyze and support implementation of data integrity best practices

•Support or lead resolution of software-related corrective action projects (CAPA)

Required Skills

Minimum

•Bachelor's degree, preferably in Engineering, Computer Science, Information Systems, or similar discipline

•5+ years of experience in software/database applications as Analyst and/or QA, preferably with Quality Management Systems

•2+ years of experience with software validation in a medical device environment

•Expert level of proficiency with MS Excel

•Experience with PLM, ERP, LMS and other QMS applications

•Familiarity with software development lifecycle (SDLC) processes and methodologies

•Strong working knowledge of the FDA Quality System Regulation, ISO 13485, and the EU Medical Device Regulation 2017/745

•Demonstrated knowledge and proficiency in the application of 21 CFR Part 11, EN 62304, ISO 14971, and other standards, regulations and guidance related to validation of software computerized systems.

•Knowledge of manufacturing and quality systems applications and workflow

•Ability to quickly learn new business processes and software applications

•Excellent analytical skills and ability to translate process requirements into clear, precise and readily verifiable specifications

•Demonstrated knowledge and proficiency in quality principles and best practices

•Strong collaboration skills to effectively communicate with both business and technical teams

•Effective oral, written and technical writing communication skills

Preferred:

•Advanced degree in Computer Science, Software Engineering, or similar discipline

•ASQ CSQE (Certified Software Quality Engineer) or similar certification

•Experience with Agile PLM, TrackWise and/or SAP

•Experience implementing PLM, ERP or other QMS systems

•Knowledge and proficiency in the application of AAMI TIR 36, EN 62304, ISPE GAMP, EN 62366, IEC/TR 80002-1, and other standards, regulations and guidance related to validation of software and computerized systems

•Knowledge and proficiency with Medical Device cybersecurity standards and industry guidance

•Demonstrated project management skills

Other:

•Travel requirements are moderate, but may include both domestic and international locations. Travel to facilities would be about 2 - 3 days duration each trip with total travel expected to be less than 5%.

•Hybrid work schedule: Employee shall balance remote work with the need and benefit of being in the office, typically a minimum of 1-2 days per week.

•Mental demands - work is detail oriented, often with multiple priorities. The environment is deadline sensitive and may be exposed to high-pressure situations. Some of the work requires intense concentration for short periods of time.

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