Quality Engineer

Abbott • Westford, MA

3d • Onsite

About The Position

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

Requirements

• 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.

Nice To Haves

• 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.)

Responsibilities

• 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.
• Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members.
• 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.
• Plans, organizes, and prioritizes own daily work routine to meet established schedule.
• Exercises authority and judgment within defined limits to determine appropriate action.

Benefits

• 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
• FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level