Senior Specialist Quality Assurance
4 weeks ago
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre always looking towards the future, anticipating changes in medical science and technology.
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Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelorâs degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
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The Opportunity
This position works out of our Alameda, CA location in the Abbott Diabetes Care Division, where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Weâre revolutionizing the way people monitor their glucose levels with our new sensing technology. Â
The Senior Specialist Quality Assurance participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products that ensures digital applications and firmware produced by ADC is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. This person will monitor design controls that govern the development, verification, validation, use, and maintenance of medical device software. The Senior Specialist Quality Assurance will also coordinate activities with other engineering disciplines, departments, and contractors.
What youâll work on
- Reviews change plans for impact to project deliverables, and provides guidance to the document owners regarding changes to software requirements specifications, labeling content, and software design descriptions for Abbottâs suite of diabetes management software (cloud and mobile).
- Reviews test plans and test reports to ensure all software changes are verified, and software system is adequately regressed across all environments in accordance with design controls and Quality System Requirements.
- Monitors implementation of defect management process and provides guidance to Systems and V&V teams to ensure software bugs are logged, investigated, tested and dispositioned.
- Active participant in an Agile software development process, including daily Scrum and other recurring Sprint ceremonies.
- Completes software quality tasks in accordance with current Quality System Requirements.
- Works independently with objectives given by SWQA Manager.
- Can plan and coordinate own work according to higher-level project schedules. Including direction of contract personnel to ensure projects come to fruition in a timely manner.
- 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 Abbott 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.
- Will also estimate, plan, schedule and review own and othersâ work products and be accountable for the quality of those reviews and delivery on schedule.
- Considered SWQA compliance SME in support of external/internal audits.
Required Qualifications
- Bachelorâs degree, or equivalent experience, in a scientific, technical, or engineering discipline.Â
- 5 to 8 yearsâ experience in Software Quality Assurance and/or Software Testing experience.Â
- Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements.
- Must have 2 - 4 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices and mobile applications.
Preferred Qualifications
- Must have excellent oral and written communication skills.Â
- ASQ Certifications a plus.
- Medical Device experience strongly preferred.
- Cyber security, medical mobile applications or cloud computing experience preferred.
What We Offer
At Abbott, you can have a good job that can grow into a great career. We offer:Â
- Training and career development, with onboarding programs for new employees and tuition assistance Â
- Financial security through competitive compensation, incentives and retirement plans Â
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programsÂ
- Paid time off Â
- 401(k)Â retirement savings with a generous company matchÂ
- The stability of a company with a record of strong financial performance and history of being actively involved in local communitiesÂ
Learn more about our benefits that add real value to your life to help you live fully:â¯Â www.abbottbenefits.com Â
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Â
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $95,500.00 â $190,900.00. In specific locations, the pay range may vary from the range posted.
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