Develops, establishes and maintains software quality engineering methodologies, systems, and
practices which meet BSC, customer, and regulatory requirements. Serves as a Software Quality
representative to improve awareness, visibility, communication on quality initiatives to
support departmental, functional, site, divisional and corporate quality goals and priorities.
Provides focused software quality engineering support within new product development,
operational, or system/services support.
Functional Engineering Roles include: Manufacturing Software & Computerized System Validation
? Identify and implement effective process control systems to support the development,
qualification and validation of software/computer systems used in medical device/combination
device manufacturing equipment to meet or exceed internal and external requirements.
? Acts as an effective leader or team member in supporting software quality disciplines,
decisions, and practices.
? Apply sound, systematic problem-solving methodologies in identifying, prioritizing,
communicating, and resolving software quality issues.
? Assure in the development and execution of streamlined business systems which effectively
identify and resolve software quality issues.
QUALIFICATIONS Skills/Knowledge Required
? Understanding of regulatory requirements as defined in the QSR/cGMPs for manufacturing
equipment software/computer systems.
? Understanding of software/computer system validation requirements as defined by regulation
and guidance ? specifically 21CFR820.70(i) and ?The General Principles of Software Validation?
? Understanding of development activities for PLC?s an SCADA?s
? Understanding of electronic record and signature requirements as defined by regulation
? Able to provide clear and concise direction for the completion of software/computer system
validation and maintenance activities
? Strong written/verbal communication skills.
? 5-10 years experience in software sciences
? 3-5 years experience with medical device manufacturing equipment
? Experience with the validation of manufacturing equipment in a regulated environment
Experience that would be a plus
? SDLC Methodologies
? SAP or other ERP systems
? Vendor Audits
? Bachelor of Science degree in software sciences or equivalent
See Description Above
Searchable Keywords: Sr. Software Quality Engineer / gj-mo
Years of Experience Required: 3-5 Years
Expected Travel Time: About 25%