Manufacturing Quality Engineer

Amcor
United States
Workplace: OnsiteFull timeFunction: QA, Test & Release EngineeringExperience: 2+ yearsEducation: bachelorsSkills: ["Cross-functional collaboration","Interpersonal communication","Results orientation","Multi-tasking","Organizational skills"]

Ensure compliance with the company Quality Management System and customer requirements by supporting manufacturing with quality engineering. Drive process and product validations (IQ/OQ/PQ), FMEA, DOE, quality metric tracking, and continual improvement activities. Support SPC implementation, engineering change order quality processes, audits, and corrective/preventive actions. Work cross-functionally across Process Engineering, Operations, and Product Development while applying ISO 13485 and FDA medical device requirements.

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FursaFursa
Amcor
Amcor
1 month ago

Manufacturing Quality Engineer

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Source: Company careers pageValidated by: Fursa AI
Last checked: 22 hours agoStatus: Live

Job Summary

Ensure compliance with the company Quality Management System and customer requirements by supporting manufacturing with quality engineering. Drive process and product validations (IQ/OQ/PQ), FMEA, DOE, quality metric tracking, and continual improvement activities. Support SPC implementation, engineering change order quality processes, audits, and corrective/preventive actions. Work cross-functionally across Process Engineering, Operations, and Product Development while applying ISO 13485 and FDA medical device requirements.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Mid level

Key Responsibilities

  • •Assist with process validations (IQ, OQ, PQ) and product validations per customer requirements and ISO-11607.
  • •Support manufacturing by analyzing failures and executing preventive/corrective action processes for internal and external issues.
  • •Facilitate FMEA and perform DOE; track, trend, and report quality metrics.
  • •Implement and sustain statistical process controls (SPC) and support quality activities for engineering change orders.
  • •Conduct audits, report findings, determine corrective and preventive actions, and support continual improvement (e.g., 5S, Kaizen, lean methods).

Pay and Benefits

Perks:Health InsuranceDentalVisionPaid LeaveHsaLife InsuranceRetirementParental Leave

Key Requirements

  • •Assist with process and product validations (IQ, OQ, PQ) aligned to customer requirements and ISO-11607.
  • •Analyze failures and drive preventive/corrective action processes for internal and external issues.
  • •Facilitate FMEA and perform Design of Experiments (DOE), including tracking/trending and reporting quality metrics.
  • •Strong statistical background with working knowledge of SPC and SPC software (Minitab preferred).
  • •Two or more years of quality engineering experience (medical or food flexible packaging preferred) and familiarity with ISO-13485 or ISO 9001 and FDA medical device regulations.
Experience:2+ yearsMedical devicesFood packagingFlexible packaging
Education:Bachelor's
Skills:Cross-functional collaborationInterpersonal communicationResults orientationMulti-taskingOrganizational skills
Certifications:Six Sigma Green BeltSix Sigma Black Belt
Tech Stack:ISO 13485ISO 9001FDA Medical DevicesISO-11607FMEADOESPCMinitabMS OfficeIQOQPQ5SKaizenLeanRoot Cause AnalysisGauge R&RCorrective ActionsPreventive Actions

Company Brief

Amcor
Global packaging company that designs and manufactures flexible and rigid packaging solutions for food, beverage, healthcare, personal care, and home care products. Focuses on improving product protection, shelf life, recyclability, and sustainability.
Industry: Printing & Packaging
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Zurich, Switzerland
Founded: 1860
WebsiteLinkedIn