Staff Quality Engineer

Job Title

Staff Quality Engineer

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 of which you dream.
• 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

We currently have an opening for a Staff Quality Engineer for the Vascular division. This role can be located at our Westford, MA location.

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 do:

Develop and implement strategies for Process/Quality Engineering that help to ensure delivery of highest quality product to the customer.

Core Job Responsibilities:

• Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions through structured Problem Solving.

• Utilize quality tools, including Gage Repeatability & Reproducibility (R&R), Cp/Cpk, and Statistical Process Controls (SPCs); methodologies, including Six Sigma and Lean Manufacturing; and manufacturing concepts, including Value Stream Mapping, 5S, and Visual Workplace.

• Develop product quality plans, documents, and systems by creating product specifications, quality specifications, and quality plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.

• Accountable for Design Verification a Validation (V&V) activity planning & execution, including identifying root causes and implementing corrective and preventative actions.

• Lead design test and inspection method development, and lead method validation activities, including writing, executing, and analyzing various types of process validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Performance Qualification (PPQ).

• Ensure Design History File (DHF) content completion, integrity, and regulatory & standards compliance with FDR 21 CFR 820, ISO 13485, and Good Manufacturing Practices (GMPs)

  Support and ensure internal and external audit responses.

  Support and ensure on time product re-certifications.

• Responsible for identifying issues through data queries and analytics to aid in decision making, implement complex product stops & develop release criteria.

• Develops and implements Process Monitoring Systems or other early warning systems that can detect and identify critical process inputs and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.

• Leads Product/Process improvement efforts by identifying methods to capture quality metric data and by identifying & performing appropriate analysis methods to enhance sustaining product quality.

• Coaches and develops cross-functional teams with expertise in problem solving, CAPA, and data analytic tools

• Complete Document Change Request Reviews in a timely and objective manner.

• 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.

• Ensure compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

• Supervise, develop, and lead junior Quality Engineers.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required Qualifications

• Bachelor’s degree in Engineering or related field or an equivalent combination of education and work experience.
• Minimum 9 years Related work experience with a strong understanding of specified functional area.
• Related work experience with a complete understanding of specified functional area.
• Comprehensive knowledge of a particular technological field. Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships.
• Is recognized as an expert in work group and across functions. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Has broad knowledge of various technical alternatives and their potential impact on the business.

Preferred Qualifications

• Medical Device experience, highly preferred.
• Has demonstrated experience of statistical analysis and problem-solving techniques
• Understands the regulated business environment and interfaces with a variety of management levels, requiring the coordination of activity across the organization.  Provides Quality leadership across the organization.
• Practical understanding of statistics
• Six Sigma Green Belt or Black Belt Certifications, preferred.

Apply Now

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.

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