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.

     

JOB DESCRIPTION:

What You’ll Work On

This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the division.

Key Responsibilities:

• Create and conduct trainings for company personnel on the divisional software development and validation processes.
• Partner with Design and Manufacturing Engineering teams to complete system/software requirements and other verification and validation tasks.
• Develop and execute software validation protocols that are traceable to system/software requirements.
• Implement and manage solutions for code control, including administering Code Control and Software Event/Defect Tracking systems.
• Assist in completing and maintaining risk analysis with a focus on software-related risks.
• Design and implement product and process improvement methodologies, such as Six Sigma and Lean Manufacturing.
• Apply systematic problem-solving methods to identify, prioritize, communicate, and resolve issues.
• Conduct software scoping and Part 11 audits.
• Support all company initiatives as identified by management, ensuring alignment with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

 Required Qualifications

• Bachelor's Degree Engineering or Technical Field or an equivalent combination of education and work experience

• Minimum 7 years of Software Quality Engineering experience.

• Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485.

• Advanced computer skills, including statistical/data analysis and report writing skills.

• Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.

• 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.

• Detailed knowledge of FDA (including 21 CFR Part 11), GMP, IEEE 1012, IEC 62304, EN 61010, EN 60601 and ISO 13485 preferred.

• Demonstrated and impactful project management and/or leadership skills, including the ability to serve as a quality team lead and resolve quality-related issues in a timely and effective manner.

• Statistical/data analysis preferred.

• Prior medical device experience preferred. ASQ CSQE certification desired.

• Strong organizational and follow-up skills, as well as attention to detail.

• Advanced Information Technology and data mining skills. Prior medical device experience preferred.

• ASQ CSQE certification desired.

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

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

$83,600.00 – $167,200.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ID Infectious Disease

        

LOCATION:

United States > San Diego : 4545 Towne Center Court

     

ADDITIONAL LOCATIONS:

United States > Lake Forest : J55, United States > South Portland : 65 Gannett Drive

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf