Quality Engineer

Quality Engineer

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.

We are seeking a Quality Engineer for our Westford, MA location for our Vascular division. This role is fully onsite.

The Quality Engineer provides Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provides Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. This role will include primarily working on and leading project teams to drive process/Quality improvements.

• Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
• May be responsible for querying & bounding data to support implementation of complex & documenting release criteria.
• Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members.
• May be responsible for creating risk analyses and FMEAs.
• Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.
• Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
• Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials.
• Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks.
• Leads a project team of moderate scope to drive Quality improvements or to address Quality concerns.
• Provides guidance to less experienced staff.
• Acts as a mentor to lower-level individual contributors.
• Influence exerted at peer level and occasionally at first levels of management.
• Plans, organizes, and prioritizes own daily work routine to meet established schedule.
• Exercises authority and judgment within defined limits to determine appropriate action.
• Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.

• Bachelor's Degree or an equivalent combination of education and work experience
• Minimum 2 years related work experience with a good understanding of Quality Engineering
• Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function.
• Will perform this job in a quality system environment.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

• Has lead or been part of moderate to large project teams. Is familiar with project management principles and can demonstrate knowledge.
• Has worked in a regulated medical industry (pharmaceutical, medical device, etc.) and has an understanding of ISO 13485 requirements.
• Has worked on resolving nonconformances through CAPA or other means, understands problem solving tools and their applications.
• Has a technical background and can demonstrate aptitude of technical skills as they apply to process monitoring, manufacturing improvements, and basic product design.
• Has had previous Quality Engineering experience and is comfortable with key Quality documentation and their use (ex. FMEAs, RAM, CAPA, Quality specifications, etc.)

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