Software Design Quality Manager

Abbott 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. Our 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

Career development with an international company where you can grow the career you dream of.

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

An excellent retirement savings plan with a high employer contribution

Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html)

student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html)

education benefit - an affordable and convenient path to getting a bachelor's degree.

A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our

San Diego, CA

location. The business group this role resides in is the

Abbott Rapid Diagnostics Infectious Disease

team (ARDx ID). We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott?s diagnostics instruments, providing lab results for millions of people

This website is an example of some of the division's products: ID NOW COVID-19 2.0 | Abbott Point of Care (https://www.globalpointofcare.abbott/us/en/product-details/id-now-covid-19-us.html)

What You'll Work On

In this role, you will manage resources for the Software Quality department, set department goals, develop and maintain processes and procedures, and ensure adherence to the software development lifecycle across the division.

In addition:

Develop, maintain and oversee the divisional software development and validation program.

Develop and conduct training of company personnel for the divisional software development and validation program.

Work with Design and Manufacturing Engineering in the completion of system / software requirements and other verification and validation processes.

Review and approve product software design history file deliverables, such as development plans, verification protocols and reports, and traceability matrices.

Develop and implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.

Assist in the completion and maintenance of risk analysis, focused on software related risks.

Develops and manages department operating budget.

Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Supervises one Quality Engineer.

Maintains a safe and professional work environment.

Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

Ensure compliance to relevant FDA QSR, ISO guidelines,including IEC 62304 and 21 CFR Part 11 and AbbottCorporate requirements asthey relate to thedevelopment,validation andmaintenanceof computerized systems.

Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

Bachelor's Degree or an equivalent combination of education and work experience

Minimum 7 years related work experience.

Ability to travel approximately 5-25%, including internationally.

Preferred Qualifications

Experience working in a broader enterprise/cross division business unit model preferred.

Ability to work in a highly matrixed and geographically diverse business environment.

Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

Ability to work effectively within a team in a fast-paced changing environment.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Multi-tasks, prioritizes and meets deadlines in timely manner.

Strong organizational, planning, follow-up skills and ability to hold others accountable.

Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Experience with requirements management tools (JAMA, DOORS, is preferred.

ISO 14971: 2019 experience

Experience with a medical device background and, has in-vitro diagnostics experience (IVDD and/or IVDR preferred).

Audit experience with regulatory agencies/bodies (FDA, ISO 13485, IVDR, MDSAP, etc.) strongly preferred.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at

www.abbott.com , on Facebook at

www.facebook.com/Abbott , and on Twitter @AbbottNews.

The base pay for this position is $112,000.00 - $224,000.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com