Quality Engineer II

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The Quality Engineer is responsible for developing, implementing, and maintaining effective process control systems that support product development, qualification, and ongoing manufacturing. This role ensures compliance with internal quality standards and external regulatory requirements while driving continuous improvement initiatives across products and processes. The Quality Engineer serves as a key partner to cross‑functional teams including Engineering, Manufacturing, Microbiology, and Regulatory Affairs.

Title: Quality Engineer II

Location: Plymouth, MN

Duration: 12 Month

• Identify, develop, and implement effective process control systems to support product development, qualification, and ongoing manufacturing activities.
• Lead the implementation of process assurances, control strategies, and Corrective and Preventive Action (CAPA) systems to meet or exceed internal and external requirements.
• Assist in the development and execution of streamlined business systems to effectively identify, investigate, and resolve quality issues.
• Apply structured and systematic problem‑solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Design, plan, and conduct experiments (DOE) to support process optimization and continuous improvement initiatives.
• Develop and maintain accurate documentation including experimental protocols, reports, and technical summaries.
• Lead process control and monitoring of Critical‑to‑Quality (CTQ) parameters and specifications.
• Lead and implement product and process improvement methodologies such as Lean Manufacturing and Six Sigma.
• Lead investigations, resolution, and prevention of product and process non‑conformances.
• Participate in or lead cross‑functional teams, representing the Quality function as a core team member in decision‑making processes.
• Lead the completion, review, and maintenance of risk analysis activities (e.g., FMEA).
• Collaborate with Design Engineering to support product verification and validation activities.
• Work closely with Microbiology to ensure appropriate environmental monitoring and incorporation of microbiological requirements into product and process development.
• Support company‑wide initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory compliance.
• Ensure compliance with U.S. Food and Drug Administration (FDA) regulations, other applicable regulatory requirements, company policies, procedures, and work instructions.
• Maintain positive, collaborative communication with employees, customers, contractors, and vendors at all levels.

• Bachelor’s degree in engineering, Quality, Life Sciences, or a related technical field.
• Experience in quality engineering, process control, or manufacturing quality within a regulated environment.
• Working knowledge of FDA regulations and quality system requirements.
• Strong problem‑solving skills using structured methodologies (e.g., root cause analysis, CAPA).
• Experience with process validation, risk management, and continuous improvement tools.
• Experience in medical device, pharmaceutical, biotechnology, or regulated manufacturing environments.
• Six Sigma (Green Belt or Black Belt) and/or Lean Manufacturing certification.
• Experience with DOE, statistical analysis, and CTQ monitoring.
• Strong documentation, communication, and cross‑functional leadership skills.

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High‑Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• Met Life Legal, Met Life , and Met Life Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life‑changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives.

Abbott believes all employees are essential to creating life‑changing breakthroughs, performing key duties to create life‑changing breakthroughs.