Business System Analyst, Quality Systems

The Business Systems Analyst, Quality Systems, will ensure that validated computerized systems are implemented, maintained, and obsoleted in a state of compliance. This role will assess the performance of regulated systems. Lead, drive and own projects and ensure effective communications and cross collaborations with the business on various Computerized Systems Validation initiatives and projects. Any communications or cross collaborations with the business are to be done by Level III and above.

• Partner with management to support other quality engineering initiatives to drive them down throughout the team.
• Manage and execute the deviation process during execution of testing. Author deviation form content. Work with the customer to resolve deviations recorded during test execution or system modifications.
• Work on multiple projects and meet timelines, requiring expert multitasking skills and
• ability to prioritize work effectively.
• Facilitate and participate in internal development team’s quality reviews of requirements to ensure they are complete, consistent, comprehensible, feasible, and conform to standards and align with client business objectives.
• Drive/assist the development of business strategies, as appropriate, to guide clients and inform requirements.
• Create documentation to support the design and development of solutions, such as, but not limited to, user stories, business/product requirements documents (BRD/PRD), functional and non-functional specifications and documentation (FRD), acceptance criteria, product roadmaps, and to-be process flows and traceability matrices, meeting notes, gap analysis, etc.
• Apply knowledge of quality engineering principles to ensure compliance with regulatory requirements and impart that knowledge to junior level CSVS.
• Work closely with the SWQ Manager to collaborate with cross functional team to identify, prioritize and execute business critical quality initiatives.
• Manage conflict resolutions both transparently and proactively by continually informing manager, team, and client of progress, issues, and concerns.
• Work with end-users across the organization to gather, understand, prioritize, and define business requirements, leveraging Medical Device, Pharmaceutical experience and best-practice methods and collaborating and seeking guidance from stakeholders.
• Provide quality support to development, engineering and manufacturing functions for design control and transfer activities.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned

• Bachelor's degree in engineering, computer science or related field with 4+ years of experience, or equivalent combination of education and experience

• Advanced knowledge of Quality Engineering Principals and Regulatory Environment such as: 21CFR11, 21CFR820, Annex 11, ISO 13485, 21CFR210, 21CFR212, HIPAA/PHI, SOX, GDPR is required
• Experience with the installation, configuration, validation, and maintenance of regulated software such as Quality Management Systems, Learning Management Systems, and Clinical Trial Management Systems is preferred
• Expert knowledge of GAMP guidelines, 21 CFR Part 11, and FDA requirements and expectations for validated systems preferred
• Medical device, pharmaceutical, biotech, or other regulated industry experience desired
• Strong oral, written and interpersonal communication skills
• Strong leadership skills with ability to work effectively within a cross-functional team.
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously
• High degree of accuracy and attention to detail
• Proficiency with MS Word, Excel, and PowerPoint

• General office environment. Willingness and ability to work on site. May have business travel from 0% - 10%. Ability to be available for on-call duty during off hours as part of a rotating schedule. Flexibility to switch weekend days off with weekdays when necessary to avoid disruption to 24/7 production environments. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 50 pounds. Must be able to move between buildings and floors. Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. Must be able to read, prepare emails, and produce documents and spreadsheets. Must be able to move within the office and access file cabinets or supplies, as needed. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

• Annual Base Salary Range:  $125,000 - $140,000/ year
• We offer a competitive compensation package plus a benefits and equity program, when applicable.  
• Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.