Job Description
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.
Development Quality Engineer II
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. 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 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 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
Structural Heart Business Mission:
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. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.
We are seeking a high caliber Development Quality Engineer II. A development quality engineer assures new or iterative products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
What You'll Work On
Execute on-time completion of design control deliverables
Design verification and validation test planning
Design verification and validation test protocols, execution and reports
Design input output trace matrix
Design History File organization
Customer, system, and product requirement review
Regulatory responses and submissions
Risk/hazard analysis and risk management plan/reports
Design specification reviews
Quality plans
Design change plan/reports
Investigate internal and external audit findings and write responses
Corrective and preventive action resolution
Complete document change requests
Ability to work independently with minimal/no supervision
Maintain high standards for content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating & resolving gaps
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
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
Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives including up to 10% travel and regular predictable attendance
Required Qualifications
Bachelor level degree in an Engineering Discipline or other Technical Field
0-2 years' experience in Quality or R&D role
Solid communication and interpersonal skills
Strong verbal communications and written communications with ability to effectively communicate at multiple levels in the Organization
Advanced computer skills, including report writing skills
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Multitasks, prioritizes, and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail
Preferred Qualifications
Degree in Mechanical, or Biomedical Engineering
Previous Quality engineering experience and demonstrated use of Quality tools/methodologies, statistical/data analysis
Prior medical device experience preferred
Working knowledge of FDA 21 CFR Part 820, GMP, and ISO 13485
Apply Now (https://www.jobs.abbott/us/en)
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 $60,000.00 - $120,000.00. 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
Development Quality Engineer II
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. 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 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 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
Structural Heart Business Mission:
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. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.
We are seeking a high caliber Development Quality Engineer II. A development quality engineer assures new or iterative products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
What You'll Work On
Execute on-time completion of design control deliverables
Design verification and validation test planning
Design verification and validation test protocols, execution and reports
Design input output trace matrix
Design History File organization
Customer, system, and product requirement review
Regulatory responses and submissions
Risk/hazard analysis and risk management plan/reports
Design specification reviews
Quality plans
Design change plan/reports
Investigate internal and external audit findings and write responses
Corrective and preventive action resolution
Complete document change requests
Ability to work independently with minimal/no supervision
Maintain high standards for content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating & resolving gaps
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
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
Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives including up to 10% travel and regular predictable attendance
Required Qualifications
Bachelor level degree in an Engineering Discipline or other Technical Field
0-2 years' experience in Quality or R&D role
Solid communication and interpersonal skills
Strong verbal communications and written communications with ability to effectively communicate at multiple levels in the Organization
Advanced computer skills, including report writing skills
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Multitasks, prioritizes, and meets deadlines in timely manner
Strong organizational and follow-up skills, as well as attention to detail
Preferred Qualifications
Degree in Mechanical, or Biomedical Engineering
Previous Quality engineering experience and demonstrated use of Quality tools/methodologies, statistical/data analysis
Prior medical device experience preferred
Working knowledge of FDA 21 CFR Part 820, GMP, and ISO 13485
Apply Now (https://www.jobs.abbott/us/en)
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 $60,000.00 - $120,000.00. 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
Key skill Required
- HTML
- Business Development
- Data Analysis
- Quality Management
- Analysis
- Attention to Detail
- Audit
- Biomedical Engineering
- Business Objectives
- Career Development
- Clinical Research
- Collaboration
- Communication
- Compliance
- Corrective and Preventive Action
- Design
- Design Change
- Design Control
- Design History
- Design Specification
- Development
- Discipline
- Environmental
- Environmental Management
- Functional Management
- Hazard Analysis
- Healthcare
- History
- Influence
- Interpersonal Skills
- ISO 13485
- Iterative
- Management
- Management Plan
- Management Systems
- Medical Device
- Meets Deadlines
- Partnership
- Preventive Action
- Progressive
- Provision
- Quality Engineering
- Regulatory Requirements
- Reimbursement
- Report Writing
- Research
- Risk Management
- Security
- Standard Of Care
- Standards Compliance
- Strategy
- Supervision
- Test Planning
- Test Protocols
- Validation
- Verification and Validation
- Work Independently
- Writing
- International
