Quality Engineer II
Quality Engineer II
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$ 60000 - 120000
1 Vacancy
Job Description
JOB DESCRIPTION:
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.
- 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 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.
This position works out of our Atlanta GA location in the Heart Failure Abbotts Heart Failure (HF) business were developing solutions to diagnose monitor and manage heart failure allowing people to restore their health and get on with their lives.
This Quality Engineer II is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development manufacturing or system/services support.
What Youll Work On
Identify and implement effective process control systems to support the development qualification and on-going manufacturing of products to meet or exceed internal and external requirements
Lead in the implementation of assurances process controls and CAPA systems designed to meet or exceed internal and external requirements
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
Apply sound systematic problem-solving methodologies in identifying prioritizing communicating and resolving quality issues
Design and conduct experiments for process optimization and/or improvement
Appropriately document experiment plans and results including protocol writing and reports
Lead process control and monitoring of CTQ parameters and specifications
Lead and implement various product and process improvement methodologies (e.g. Six Sigma and Lean Manufacturing)
Lead the investigation resolution and prevention of product and process non-conformances Participate in or lead teams in supporting quality disciplines decisions and practices (e.g. represent the Quality function as a Core Team Member)
Lead in the completion and maintenance of risk analysis
Work with design engineering in the completion of product verification and validation
Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
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
- Bachelors Engineering or Technical Field or equivalent experience
- 2-5 years Engineering experience and demonstrated use of Quality tools/methodologies.
- Detailed knowledge of FDA GMP ISO 13485 and ISO 14971 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 Prior medical device experience preferred. Experience implementing various product and process improvement methodologies (e.g. Six Sigma and Lean Manufacturing).
- ASQ CQE or other certifications 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 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.
Preferred Qualifications
- Masters Degree
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 $120000.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
HF Heart Failure
LOCATION:
United States > Atlanta : 387 Technology Circle NW Suite 500
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder bent wrists) 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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