Quality Engineer II | Medical Devices | CAPA & Compliance

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

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401K match

Paid Time Off

Tuition Reimbursement

Employee Stock Purchase Plan

Parental Leave

Job summary

Jabil, a global leader in engineering and manufacturing, seeks a Quality Engineer II for its Nypro operation in a regulated medical device environment. You will develop QA plans, drive CAPAs, and collaborate with R&D, manufacturing, and supply chain to ensure product quality and process compliance.

The role requires a B.E. with 2 years in a regulated quality setting, strong knowledge of ISO 9001/13485 and IATF 16949, and proficiency in SPC/MSA.

Qualifications

• Bachelor's degree in Engineering and 2 years in a regulated quality role within manufacturing.
• Strong understanding of quality management systems (ISO 9001, ISO 13485, IATF 16949).
• Proficiency in SPC, MSA and other quality tools; root cause analysis methodologies (8D, 5 Whys, Fishbone).
• Supplier quality experience is a plus; Six Sigma Green Belt preferred.
• Excellent problem-solving, analytical, and decision-making skills.
• Strong communication and teamwork; proficient with MS Office; read/drawings/specs.

Responsibilities

• Develop, implement, and maintain quality control plans and procedures for new and existing products.
• Conduct CAPA activities and perform RCA to address quality issues.
• Perform statistical analysis to identify trends and validate processes.
• Participate in design reviews and provide QA input on product/process designs.
• Support supplier quality activities including audits, qualification, and monitoring.
• Lead internal and external audits to ensure ISO 9001, ISO 13485, IATF 16949 compliance.
• Train and mentor junior QA personnel; develop and implement MSA studies.
• Prepare and present quality performance reports to management.

Skills

SPC

MSA

Root cause analysis

Six Sigma

Communication

MS Office

Education

Bachelor's degree in Engineering

Job description

Jabil, a global leader in engineering and manufacturing, seeks a Quality Engineer II for its Nypro operation in a regulated medical device environment. You will develop QA plans, drive CAPAs, and collaborate with R&D, manufacturing, and supply chain to ensure product quality and process compliance.

The role requires a B.E. with 2 years in a regulated quality setting, strong knowledge of ISO 9001/13485 and IATF 16949, and proficiency in SPC/MSA.