The Program Manager will be instrumental in dictating the software documentation and development process, ensuring that it adheres to company-defined standards. You will act as the liaison between the Product Management, Software, Quality Assurance, and Regulatory Teams. We are seeking individuals who are ready for a challenge and are driven to meet the needs of our patients and growing business.
Manage high-level documentation processes and drive teams to follow such processes.
Administer design control software utilized in the documentation and development process.
Review and approve software system validations and changes.
Assist in the creation and review of content such as requirements documents, test plans, risk assessments, hazard analyses, etc.
Generate, review and/or maintain records or documents in a detailed and consistent manner.
Participate in the planning, execution and follow up on internal and external quality audits.
Ensure compliance with applicable State and Federal regulations and Company Policies, Procedures, Goals and Objectives.
Train various team members on internal Quality Management policies.
Coordinate and manage continuous improvement projects.
Own deviation and change control records.
Bachelor's Degree from a top-tier university.
5+ years of professional work experience in software product/program management, compliance management, or information technology.
Experience with validation of software/IT systems in a regulated industry such as medical devices or financial services.
Working knowledge of the development of protocols for the validation of complex computer systems.
Knowledge of all phases of the product development life cycle including design, implementation, debugging, verification, qualification, and production support.
Strong presentation and communication skills required.
Experience with Quality Systems Standards (ISO13485, FDA CFR 21 Part 820 and Part 11) highly desired.
Experience with software verification and validation of medical device software desired.
Experience with Laboratory Automation Systems (LIMS/LIS) a plus.
Demonstrated high level of initiative and ability to function superbly in both individual and team environments.
Ability to work in a complex and fast moving environment and handle stressful situations and deadline pressures well.