Support the design, development, and validation of software for manufacturing processes in a medical device regulated environment.
Primarily supports Clearwater. May be requested to support other Bausch & Lomb facilities as needed.
Execute Software Quality Assurance activities in compliance with applicable policy and procedures. Perform Software Process assessments to facilitate software process improvement initiatives (i.e. Testing, Risk Management, procedural improvements).
Assure compliance to all Global Software Quality Assurance initiatives, directives and procedures.
Provide training to their respective groups on all Global Software Quality Procedure and their associated templates.
Be responsible for the review and approval of all validation project documentation and assurance that the project meets all B+L and regulatory requirements.
Some of the Software Quality Assurance activities may include authoring validation plans, assisting in defining accurate requirements, developing test scripts, training the project in software validation practices as it relates to GMP, reviewing /approving validation documents, following through on critical action items, developing validation reports and supporting the overall B+L software validation effort.
Internal: IT, engineering, D&R, quality and manufacturing functional representatives.
External: Software/Equipment suppliers, external auditors/regulatory authorities.
Bachelor's Degree in Computer Science or related technical degree
ISO 13485, ISO 9001, GMPs, MDD required. CMDR, JPAL, ISO 14001, OHSAS 18001, and other regulations are desired. Working knowledge and experience in a regulated medical device or pharmaceutical industry and experience with managing external agency audits necessary.Good understanding of 21CFR11 electronic signature requirements.
ASQ Certified Software Quality Engineer (CSQE) would be a plus but not a prerequisite.
Solid experience with leading project teams by providing guidance and recommending changes. Strong written and oral communication and interpersonal skills.
Working knowledge of PLC, MMI (man / machine interface), SCADA, machine control systems, and Bridgeworks.
Computer & Information Technology Skills including Windows, Word, Excel, Power Point, Project, Visio, statistical software (i.e. Minitab).
5+ years hands on experience in automated manufacturing processes. 3+ year's hands-on experience with Software Quality in a GxP environment.