Abbott is looking for a Compliance Quality Software Lead to ensure that SWQA computerized systems used in the support of the Quality System and development of ADC customer facing products are developed, validated, and maintained in compliance with regulatory and corporate requirements.
Requirements
- Minimum 6 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices and mobile applications.
- Minimum 8 years of experience in Software Testing and/or Software Quality Assurance.
- Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11.
- Has knowledge of Design Control requirements.
- Must be technically strong and have experience leading a test engineering or software quality team.
Responsibilities
- Ensure that SWQA computerized systems used in the support of the Quality System and development of ADC customer facing products, are developed, validated and maintained in compliance with regulatory and corporate requirements.
- Provide quality engineering expertise to investigate, audit, analyze, propose improvements, and manage processes in the Quality Management Systems and development of ADC consumer products and mobile applications.
- Author, change and update software QA procedures as applicable.
- Ensure compliance with all applicable Abbott Diabetes Care Quality Management policies and with all applicable regulatory and Abbott corporate requirements.
- Serve as primary representative for software quality assurance functions for each Product Development Team assigned.
- Evaluate complaints, CAPAs, internal audits findings, customer audits findings and propose corrective and preventive actions.
- Develop and implement Verification and Validation policies, status reports, and strategies.
Other
- Must have excellent oral and written communication skills.
- B.S. in a Scientific, Technical or Engineering discipline. Combination of work and education will be considered.
