Engineer II Software Quality
Engineer II Software Quality
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$ 60000 - 120000
1 Vacancy
Job Description
JOB DESCRIPTION:
Engineer II Software Quality
About Abbott
Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were always looking towards the future anticipating changes in medical science and technology.
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. Youll 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 bachelors 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.
The Opportunity
This position works out of our Westfield IN location in the Structural Heart division.
Structural Heart Business Mission: why we exist
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout division.
What Youll Work On
- 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.
- Create and execute or direct software validation protocols traceable to system/software requirements.
- 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.
- Design and implement various product and process improvement methodologies (i.e Six Sigma and Lean Manufacturing).
- Apply sound systematic problem solving methodologies in identifying prioritizing communicating and resolving issues.
- Software scoping and Part 11 audits.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) Environmental Management Systems (EMS) and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations other regulatory requirements Company policies operating procedures processes and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees customers contractors and vendors.
Required Qualifications
Education
Bachelors Degree ( 16 years) in Engineering or Technical Field or an equivalent combination of education and work experience
Experience/Background
- Minimum 2 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. Advanced Information Technology and data mining skills. Prior medical device experience preferred. ASQ CSQE certification desired.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- 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 including internationally.
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
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 on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
$60000.00 $120000.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
SH Structural Heart
LOCATION:
United States > Westfield: 1820 Bastian Court
ADDITIONAL LOCATIONS:
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) Continuous standing 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: EEO is the Law link - Espanol:
Employment Type
Full-Time
Key Skills
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