Staff Quality Engineer

Abbott • Plymouth, MN

299d • $97,300 - $194,700

About The Position

This position works out of our Plymouth, MN location in the EP division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As a Staff Quality Engineer, you'll have the chance to be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

Requirements

• Bachelor’s Degree (± 16 years) in Engineering or Technical Field with an equivalent combination of education and work experience.
• Minimum 8+ years’ experience.
• Demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Solid communication and interpersonal skills.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as both a leader and individual contributor in a fast-paced, changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes, and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to maintain regular and predictable attendance.

Nice To Haves

• Demonstrated supervisory experience preferred.
• ASQ CQE or other certifications preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Prior medical device experience preferred.

Responsibilities

• 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, coach, and mentor non-exempt and lower-level exempt personnel.
• 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 nonconformance’s.
• 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 Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Perform other related duties and responsibilities, on occasion, as assigned.
• Manage & monitor site NCMRs/CAPAs including reporting requirements, provide detailed updates and information in support of quality, also liaising with other Abbott sites to ensure compliance to quality system.
• Perform or review manufacturing non-conformances reports, CAPA, failure investigations and audit findings to report manufacturing related issues that may impact quality and recommend courses of corrective action.
• Prepare metrics for NCMRs / CAPA suppliers’ performance, analyze process data and trends and drives optimization and improvement.
• Perform and report line defects trend analysis.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree