Senior Business Systems Analyst

What You'll Work On

• Work closely with management to support other quality engineering initiatives to drive them down throughout the team.
• Work on multiple projects and meet timelines, requiring expert multitasking skills and ability to prioritize work effectively.
• 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.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• 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.
• 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.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• 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.
• 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.

What You'll Bring

• Bachelor’s degree required, in engineering, computer science, or related discipline with 12+ years related experience, preferably in the medical device, pharmaceutical, or similar FDA-regulated industry, or an equivalent combination of education and experience.
• Required to have advanced knowledge of Quality Engineering Principals and Regulatory Environment such as: 21CFR11, 21CFR820, Annex 11, ISO 13485, 21CFR210, 21CFR212, HIPAA/PHI, SOX, GDPR
• Experience with the installation, configuration, validation, and maintenance of regulated software such as Quality Management Systems, Learning Management Systems, and Clinical Trial Management Systems
• Expert knowledge of GAMP guidelines, 21 CFR Part 11, and FDA requirements and expectations for validated systems preferred.
• 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.

Working Conditions

• General office environment. Business travel from 0% - 10%. Potential exposure to blood-borne pathogens. Requires some lifting and moving of up to 25 pounds. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.

• 
  Alameda, CA
• Starting Base Salary is $132,430/year - $188,053/year.
• Individual compensation will vary over time-based on factors such as performance, skill level, competencies, work location and shift.