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 you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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

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 treatment of vascular disease.

What You’ll Work On

• Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
• Identify, analyze, investigate, monitor, and document patterns and trends in post marketing surveillance data aspart of the CAPA system.
• Analyze and investigate product complaints from the field as part of post marketsurveillance requirements.
• Communicate and educate management, R&D, marketing, sales organization andother departments, as well as external customersabout product performance. 
• Ensure that information andinsight gained from the investigations and correctiveactions is fed back to the R&D and marketingorganizations as part of the risk management and design input systems.  
• 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.
• May be responsible for implementing product stops & documenting release criteria.
• Develops and implements product quality plans, documents, and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
• Responsible for risk analyses and FMEAs.
• Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
• Collects and analyzes Lead Manufacturing process defect data Product/Process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development.
• Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
• Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel.  May lead a project team.
• Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions.
• May interact with vendors.

(Planning/Organization)

• Plans and organizes non-routine tasks w/approval.
• Initiates or maintains work schedule.
• Establishes priorities of work assignments.

(Decision Making/Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution.

• Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

Required Qualifications

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Works independently or under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
• May provide work direction and guidance to exempt and/or skilled nonexempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.

(Influence/Leadership) 

• Establishes and cultivates an extensive network of support to facilitate completion ofassignments.  
• Participates in the developmentof less experienced staff by setting an example, providingguidance and work direction,and offering counsel.  
• May lead a project team.  Participates in determining goalsand objectives for projects.  
• Influences middle management on technical or business solutions.  May interactwith vendors. 

(Planning/Organization) 

• Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. 
• Establishes priorities of work assignments.

(Decision Making/Impact) 

• Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
• Failure to obtain results orerroneous decisions orrecommendations would typically result in serious program delays and considerable expenditure of resources.
• May include supervisory responsibilities.

EDUCATION AND EXPERIENCE YOU’LL BRING:

Minimum Education

Bachelor's degree (Engineering/Life Sciences) plus 8+ years of related work experience 

with a strong understanding of specified functionalarea, or an equivalent combination 

of education and work experience. Advanced degree preferred.

Minimum Experience / Training Required

• Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies/relationships.
• Will perform this job in aquality system environment.  
• Failure to adequately perform tasks can result in noncompliance with noncompliance with governmental regulations.
• CQE Certification a plus
• Medical Devices experience preferred
• Electronic
• CAPA experience
• Experience working with Quality Systems
• Data Analysis experience
• Risk Management experience

(Cognitive Skills) 

Works on problems of diverse scope whereanalysis of data requires evaluation of identifiable factors.  

Exercises judgment within generally definedpractices and policies in selecting methods and techniques for obtaining solutions. 

Has a sound knowledge ofvarious technical alternativesand their impact.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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 Twitter @AbbottNews and @AbbottGlobal.