Abbott
Overview
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 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 student debt program and FreeU 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 The Sr, Quality Engineer
position works onsite at our Temecula, CA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.
What You’ll Work On
Lead on-time completion of Design Control Deliverables
Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
Lead Risk Management activities from product Concept through Commercialization
Lead design test and inspection method development, and lead method validation activities
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Support manufacturing process development & qualification for new product commercialization and product changes
What You’ll Work On (Continued)
Support/lead and ensure internal & external audit responses
Support/lead and ensure on time product re-certifications
Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
Accountable for development, execution and analysis of biocompatibility and sterilization qualifications
Complete Document Change Request Reviews in a timely and objective manner
Develop and lead other team members
Perform other duties and responsibilities as assigned by management
Support/lead 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
Bachelors Degree in Engineering or Technical Field or an equivalent combination of education and work experience
Minimum 5 years of previous Quality engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, and ISO 13485
Solid communication and interpersonal skills. Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
Advanced computer skills, including statistical/data analysis and report writing skills
Preferred Qualifications
Masters Degree Preferred
Prior medical device experience preferred. ASQ CQE certification preferred. Design for Six Sigma and Critical to Quality training and experience preferred
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 travel approximately 10%, including internationally
Abbott is an Equal Opportunity Employer, committed to employee diversity.
For further information, contact: corpjat@abbott.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.
The base pay for this position is $75,300.00 – $150,700.00. In specific locations, the pay range may vary from the range posted.
Abbott 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.
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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. 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 student debt program and FreeU 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 The Sr, Quality Engineer
position works onsite at our Temecula, CA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.
What You’ll Work On
Lead on-time completion of Design Control Deliverables
Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
Lead Risk Management activities from product Concept through Commercialization
Lead design test and inspection method development, and lead method validation activities
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Support manufacturing process development & qualification for new product commercialization and product changes
What You’ll Work On (Continued)
Support/lead and ensure internal & external audit responses
Support/lead and ensure on time product re-certifications
Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
Accountable for development, execution and analysis of biocompatibility and sterilization qualifications
Complete Document Change Request Reviews in a timely and objective manner
Develop and lead other team members
Perform other duties and responsibilities as assigned by management
Support/lead 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
Bachelors Degree in Engineering or Technical Field or an equivalent combination of education and work experience
Minimum 5 years of previous Quality engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, and ISO 13485
Solid communication and interpersonal skills. Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
Advanced computer skills, including statistical/data analysis and report writing skills
Preferred Qualifications
Masters Degree Preferred
Prior medical device experience preferred. ASQ CQE certification preferred. Design for Six Sigma and Critical to Quality training and experience preferred
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 travel approximately 10%, including internationally
Abbott is an Equal Opportunity Employer, committed to employee diversity.
For further information, contact: corpjat@abbott.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.
The base pay for this position is $75,300.00 – $150,700.00. In specific locations, the pay range may vary from the range posted.
Abbott 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.
#J-18808-Ljbffr