Senior Quality Assurance Specialist
1 week ago
This is a challenging and rewarding position that requires a strong understanding of software quality assurance and testing principles, as well as excellent communication and leadership skills.
Key Responsibilities- Completes software quality tasks in accordance with current quality system requirements.
- Works independently with objectives given by quality assurance manager.
- Plans and coordinates own work according to higher-level project schedules.
- Reviews and provides lead guidance to the team regarding deliverables/activities as identified in the design control process/project plan or equivalent project plan.
- Reports unexpected events, issues or software bugs which occur during verification/validation to project team and management.
- Assists subordinate staff in recognizing the same.
- Assists in the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR Part 11 and corporate requirements as they relate to the development, verification, validation, and maintenance of medical device software.
- Software quality lead in various phases of the development lifecycle, as well as initiation of corrective and/or preventative action as it applies software development activities.
- Maintains schedule and drive to meet project schedule as aligned with project(s) goals.
- Estimates, plans, schedules and reviews own and others' work products and is accountable for the quality of those reviews and delivery on schedule.
- Considered quality assurance compliance SME in support of external/internal audits.
- Bachelor's degree, or equivalent experience, in a scientific, technical, or engineering discipline.
- 5 to 8 years' experience in software quality assurance and/or software testing experience.
- Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11.
- Must have 2 - 4 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices and mobile applications.
- Must have excellent oral and written communication skills.
- ASQ certifications a plus.
- Medical device experience strongly preferred.
- Cyber security, medical mobile applications or cloud computing experience preferred.
Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
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