Quality Engineer II- Medical Devices

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

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.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.BENEFITS PACKAGE WITH JABILCompetitive base salaryMedical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options401K matchEmployee Stock Purchase PlanPaid Time OffTuition ReimbursementLife, AD&DJBL TA - Job Requisition Process Status, and Disability InsuranceCommuter BenefitsEmployee Assistance ProgramPet InsuranceAdoption AssistanceAnnual Merit IncreasesCommunity Volunteer OpportunityThe 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.BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.Accessibility AccommodationIf you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to [e-mail] or calling 727-803-7988 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.#whereyoubelong#AWorldofPossibilities#EarlyCareer