CAPA Engineer IIAbbott • Des Plaines, Illinois, USA
CAPA Engineer II
Abbott • Des Plaines, Illinois, USA
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Communicate confidently and effectively with all levels of management peers and key stakeholders including timely escalationof quality issues. Participate in or lead the completion of CAPA projects assuring compliance quality and timeliness of records. Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis / problem solving skills). Independently investigate gathers data and perform preliminary analysis. Process requests ensuring owners are assigned and timely responses and approvals are provided in alignment with quality goals. Lead meetings and communications for CAPA updates information and concerns. Responsible for assisting with metrics and reporting on regular basis in accordance with established procedures. Support team in the delivery and oversight of CAPA training program. Assist in the initiation processing and completion of CAPA records in the electronic system. Execute and provide on-time completion of Quality Assurance engineering deliverables. Provide support and subject matter expertise during audits and inspections. Lead and / or contribute to continuous improvement initiatives and projects. Complies with U.S. Food and Drug Administration (FDA) regulations other regulatory requirements Company policies operatingprocedures processes and task assignments. Bachelors Degree in Engineering Healthcare or Life Science or an equivalent combination of education and work experience. 2 years of engineering and / or technical operational experience plus demonstrated competence . Previous CAPA and / or quality assurance / engineering experience and demonstrated use ofquality tools / methodologies. Prior medical device experience preferred. Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820) GMP and ISO13485 : 2016. Solid communication and interpersonal skills. Demonstrated and impactful project management and leadership skills including the 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. 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 changingenvironment. 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 10% including internationally. Ability to maintain regular and predictable attendance. Masters Degree in related field preferred. Six Sigma root cause analysis / problem solving training and experience preferred. Experience working in a broader enterprise / cross-division business unit model preferred.
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 114000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION : CAPA Engineer II
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. Youll also have access to :
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
- An excellent retirement savings plan with a 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 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
At Molecular Diagnostics we realize the potential of personalized care as the laboratorys most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories a global diversified healthcare innovator with a legacy of pioneering work in medical diagnostics.
The position of CAPA Engineer II within our Molecular Diagnostics Business Unit located in Des Plaines Illinois. This position is r esponsible for facilitating and executing to the CAPA process.
What Youll Work On
Required Qualifications
Preferred
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.
The base pay for this position is
$60000.00 $120000.00
In specific locations the pay range may vary from the range posted.
JOB FAMILY : Operations Quality
DIVISION : AMD Molecular
LOCATION : United States >
Des Plaines : DP01
ADDITIONAL LOCATIONS :
WORK SHIFT :
Standard
TRAVEL : Yes 10 % of the Time
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) Work in a clean room environment
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 :
Key Skills
ASP.NET,Health Education,Fashion Designing,Fiber,Investigation
Employment Type : Full-Time
Experience : years
Vacancy : 1
Monthly Salary Salary : 60000 - 120000
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