Quality Engineer II: Process Control & CAPA Lead

Abbott Laboratories; Minnetonka (MN); On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott Laboratories in Minnetonka, MN is seeking a Quality Engineer to identify and implement effective process control systems to support qualification and ongoing manufacturing of medical devices and products that meet internal and external requirements.

You will lead CAPA initiatives, apply Six Sigma and Lean methodologies, document experiments, monitor CTQ parameters, and collaborate with cross-functional teams to resolve quality issues in a fast-paced, highly matrixed environment.

Qualifications

• 2-5 years Engineering experience and demonstrated use of quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an 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.

Responsibilities

• Identify and implement effective process control systems to support qualification and ongoing manufacturing of products to meet or exceed internal and external requirements.
• Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Assist in the 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.
• Work with cross functional teams to 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 non-conformances.
• Participate in or 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.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Skills

Quality tools/methodologies

Verbal and written communication

Multitasking and prioritization

Teamwork and independent contributor

Education

Bachelor’s Degree in engineering or Technical Field

Tools

FDA knowledge

GMP

ISO 13485

ISO 14971

Job description

Abbott Laboratories in Minnetonka, MN is seeking a Quality Engineer to identify and implement effective process control systems to support qualification and ongoing manufacturing of medical devices and products that meet internal and external requirements.

You will lead CAPA initiatives, apply Six Sigma and Lean methodologies, document experiments, monitor CTQ parameters, and collaborate with cross-functional teams to resolve quality issues in a fast-paced, highly matrixed environment.