Abbott
Abbott
Posted 6 days ago
Full Time
Westford, Massachusetts
In Person
Smart Summary
Responsibilities
This position is responsible for developing and maintaining quality engineering methodologies to support new product development and manufacturing processes. The role involves leading CAPA systems, conducting process optimization experiments, and ensuring compliance with FDA and other regulatory requirements.
Qualifications
You have a Bachelor's degree in Engineering or a technical field, or equivalent experience, with 0-2+ years of engineering experience and demonstrated use of quality tools and methodologies. You possess solid communication, interpersonal, and project management skills, with advanced computer skills including statistical/data analysis and report writing.
Must Have Skills for ATS
Six Sigma
Lean Manufacturing
CAPA
FDA
GMP
ISO 13485
ISO 14971
Job Description
Job Title
Associate Quality Engineer (second shift - 3:30pm to 2:00am)
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. You’ll also have access to:
The Opportunity
This position works out of our Westford, MA location in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.
This is an onsite role. Schedule is Monday - Thursday, 10-hour shifts.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents
What You’ll Work On
This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.
MAIN RESPONSIBILITIES
This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.
• 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 Experience:
Preferred Experience:
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.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, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on X @AbbottNews.
The base pay for this position is
$50,700.00 – $101,300.00In specific locations, the pay range may vary from the range posted.
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