Quality Engineer II

Jabil • Monument, CO

7d • $65,500 - $117,900 • Onsite

About The Position

The Quality Engineer II is responsible for ensuring that products or services meet the required quality standards and specifications. They work with the organization’s manufacturing and engineering processes & employees, as well as with suppliers, to ensure final products are safe, reliable, and meet customer requirements while keeping the manufacturing process as effective as possible.

Requirements

• Bachelor’s or foreign equivalent degree in mechanical engineering, industrial engineering or a related field with 1-2 years relevant experience, OR Bachelor’s plus Master’s degree. If there is no degree, 4-8 years of relevant experience.
• Proficiency in the use of personal computers, Microsoft Office products (Excel, Word, and PowerPoint) and e-mail skills required.
• Working knowledge of a manufacturing process such as Turning, Finishing, or Sterile/non-sterile Packaging.
• Medical device manufacturing within FDA Title 21 CFR Part 820 & ISO 13485.
• Gage metrology and generation of inspection plans.
• Identifying and leading process improvement projects.
• Nonconformance, CAPA, Audit observations and complaint handling.
• Validation experience (IQ/OQ/PQ) for product, process, equipment, and/or software.
• Six Sigma and Lean tools such as DMAIC, SPC, process & value stream mapping.
• Statistical analysis that includes ANOVA, DOE, Weibull, GR&R, Capability, FMEA, KT and SPC as required.
• Customer requirements, specification & change review process, and incorporation.
• Quality documentation Change Management initiation and resolution.
• Proficiency in English: Business fluent, both written and verbal

Nice To Haves

• Proficiency preferred in use of EtQ reliance software, BabtecQ Inspection software, Windchill Change Management software, ComplianceWire Training software, Minitab or equivalent statistical software.

Responsibilities

• Responsible for day-to-day resolution of product dispositioning (scrap, rework, non-conformance records) through direct involvement as well as coordination with peers and other required departments or suppliers.
• Participate in the Quality Improvement Committee (QIC), or equivalent operations reporting, through generation of content and/or presentation during weekly area meetings.
• Participate in & support favorable Quality site metrics such as CAPAs, NCs, Audits, & Complaint handling.
• Participate in maintaining process improvements and optimization, concentrating on proactive methodologies supporting defect reduction.
• Interface and provide technical support on quality issues with the customer as needed.
• Maintain appropriate documentation as required for Quality System activities.
• Provide technical support for successful new product transfer for established or new customers.
• Leads small project or sub-project as part of a greater project.
• Role involves working with people inside Jabil, with occasional interactions with people outside the company.
• May perform other duties as assigned.
• Support activities and provide mentorship to Quality Engineer I and Quality Technicians.

Benefits

• Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
• 401K match
• Employee Stock Purchase Plan
• Paid Time Off
• Tuition Reimbursement
• Life, AD&DJBL TA - Job Requisition Process Status, and Disability Insurance
• Commuter Benefits
• Employee Assistance Program
• Pet Insurance
• Adoption Assistance
• Annual Merit Increases
• Community Volunteer Opportunity

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level