Quality Engineer II- Medical Devices

Jabil; Maple Grove (MN); On-site; USD 69,000 - 124,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Paid Time Off

Parental Leave

Holidays

401(k) retirement plan

Employee Stock Purchase Plan

Job summary

Jabil is seeking a Quality Engineer II to ensure product quality and process compliance across medical device operations. You will apply engineering principles and quality tools to drive continuous improvement within Nypro manufacturing environments.

You will support quality systems, lead CAPA and MSAs, participate in design reviews, and collaborate with R&D, manufacturing, and supply chain to resolve issues. A degree in engineering and 2 years in regulated quality is required.

Qualifications

• Bachelor's degree in Engineering or related field.
• 2 years of experience in a regulated quality role in manufacturing.
• Strong understanding of ISO 9001, ISO 13485, IATF 16949 and quality tools.

Responsibilities

• Develop, implement, and maintain quality control plans and procedures for new and existing products.
• Conduct root cause analysis and implement CAPA for quality issues.
• Perform statistical analysis to identify trends and validate processes.
• Participate in design reviews and provide quality input on product and process designs.
• Support supplier quality activities including audits and performance monitoring.
• Lead and participate in internal and external audits to ensure ISO/IATF compliance.
• Collaborate with R&D, manufacturing, and supply chain to resolve quality problems.
• Train and mentor junior quality personnel on quality methodologies.
• Develop and implement MSAs.
• Prepare and present quality performance reports to management.

Skills

Problem-solving

Analytical thinking

Communication

Decision-making

Team collaboration

Education

Bachelor's degree in Engineering

Tools

SPC

MSA

Six Sigma (Green Belt)

Job description

How will you make an impact?

The Quality Engineer II at Jabil/Nypro Inc. is responsible for ensuring product quality and process compliance through the application of engineering principles and quality tools. This role involves supporting

How will you make an impact?

The Quality Engineer II at Jabil/Nypro Inc. is responsible for ensuring product quality and process compliance through the application of engineering principles and quality tools. This role involves supporting medical device manufacturing operations, driving continuous improvement, and maintaining robust quality systems.

What will you do?

• Develop, implement, and maintain quality control plans and procedures for new and existing products.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) for quality issues.
• Perform statistical analysis of data to identify trends, opportunities for improvement, and validate processes.
• Participate in design reviews and provide quality input on product and process designs.
• Support supplier quality activities, including audits, qualification, and performance monitoring.
• Lead and participate in internal and external audits to ensure compliance with relevant quality standards (e.g., ISO 13485, IATF 16949).
• Collaborate with cross-functional teams including R&D, manufacturing, and supply chain to resolve quality-related problems.
• Train and mentor junior quality personnel on quality methodologies and procedures.
• Develop and implement measurement systems analysis (MSA) studies.
• Prepare and present quality performance reports to management.

How will you get here?

• Bachelor's degree in Engineering (Mechanical, Industrial, Electrical, or related field).
• 2 years of experience in a regulated Quality role within a manufacturing environment, preferably in plastics injection molding or medical device industries.
• Strong understanding of quality management systems (e.g., ISO 9001, ISO 13485, IATF 16949).
• Proficiency in statistical process control (SPC), measurement systems analysis (MSA), and other quality tools.
• Experience with root cause analysis methodologies (e.g., 8D, 5 Whys, Fishbone diagrams).
• Supplier Quality experience is a plus.
• Knowledge of Six Sigma methodologies (Green Belt certification preferred).
• Excellent problem-solving, analytical, and decision-making skills.
• Strong communication and interpersonal skills, with the ability to work effectively in a team environment.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Ability to read and interpret technical drawings and specifications.

The pay range for this role is $68,800 - $123,800. Job-related, non-discriminatory factors used to determine the actual offered rate include qualifications and experience, geographic location, education, external market data, and consideration of internal equity.

As part of the total rewards package, Jabil offers benefits to enhance your health, wealth, and resilient self. These include medical, dental, and vision insurance plans; paid time off accruing at a rate of 3.07 hours during your first year of employment; 4 weeks of paid parental leave; in 2026, 11 company-paid holidays (9 fixed holidays and 2 optional floating holidays), subject to change yearly; 401(k) retirement plan; and employee stock purchase plan.