Corporate Quality Engineer (Healthcare focus)

Amcor LLC; Oshkosh (WI); Vor Ort; USD 70.000 - 100.000; Vollzeit

Benefits dieser Stelle

Medical, dental and vision plans

Paid time off

Wellbeing program

Retirement Savings Plan with company 4

Tuition Reimbursement

Zusammenfassung

Amcor LLC in Oshkosh, Wisconsin is seeking a Quality Assurance Engineer to support manufacturing quality systems in compliance with ISO 13485 and customer requirements. You will assist with validations, FMEA, DOE, and SPC to drive product quality and process capability.

This role collaborates with Process Engineering, Operations and Product Development to investigate defects, perform root-cause analyses, and implement corrective actions.

Qualifikationen

• Bachelor's degree in Engineering or Science required.
• 2+ years in Quality Engineering, medical or food packaging preferred.
• Strong knowledge of ISO-13485 or ISO 9001 QMS and FDA regulations.
• Experience with FMEA, DOE, SPC and quality metrics.

Aufgaben

• Assist with IQ/OQ/PQ validations per customer requirements.
• Analyze failures, implement preventive and corrective actions.
• Lead or support FMEA, DOE, Gage R&R and SPC activities.
• Support audits and maintain the quality management system.

Kenntnisse

FMEA

DOE

SPC

Root Cause Analysis

Six Sigma

Ausbildung

Bachelor's degree in Engineering or Science

Tools

Minitab

MS Office

Gage R&R

Jobbeschreibung

Accelerate the possible by joining a winning Amcor team that’s transforming the packaging industry and improving lives around the world.At Amcor, we unpack possibility through our innovative and responsible packaging to provide solutions that benefit our customers, our people and our planet. More than 10,000 consumers worldwide encounter our products every second and rely on us for safe access to food, medicine and other goods. We value their trust by making safety our guiding principle. It’s our core value and integral to how we do business.Beyond this core principle, our shared values and behaviors unite us as we work together to elevate customers, shape lives and protect the future. We champion our customers and help them succeed. We play to win – adapting quickly in an everchanging world – and make smart choices to safeguard our business, our communities and the people we serve for generations to come. And we invest in our world-class team, empowering our colleagues to unpack their potential, because we believe when our people grow, so does our business.To learn more about playing for Team Amcor, visit www.amcor.com I LinkedIn I Glassdoor I Facebook I YouTubeJob DescriptionUnder the direction of the Quality Assurance Manager, ensures compliance with company Quality Management Systems and customer requirements in accordance with ISO 13485, and provide quality engineering support to manufacturing.WHAT YOU GET TO DOAssisting with process validations (IQ, OQ, & PQ) and product validations as per customer requirementsSupport manufacturing units with analyzing failures, preventive and corrective action processes related to both internal and external issuesFacilitate Failure Mode and Effect Analysis (FMEA)Perform Design of Experiments (DOE)Track, trend and report quality metricsResponsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.Provide support for the implementation and sustaining of statistical process controls (SPC)Provide support to engineering change order processAssist Quality manager in establishing, implementing and maintaining the quality management system.Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actionsAbility to effectively develop and perform: Validations, FMEA, Root Cause Analysis, Gauge R&R, and DOEWHAT WE VALUEAbility to work cross-functionally with Process Engineering, Operations and Product Development departmentsExcellent interpersonal and communication skillsMust be results oriented, multi-tasking, and be able to respond to urgent needs and meeting deadlinesMust have excellent organizational skills and the ability to work well both independently and as a member of a teamStrong statistical background and working knowledge of SPC software (Minitab preferred)PC Oriented (MS Office)Must have working knowledge of ISO-13485 or ISO 9001 QMSR and FDA Medical Devices RegulationsWHAT WE WANT FROM YOUBachelor’s degree in Engineering or ScienceTwo or more years of Quality Engineering Experience (medical or food flexible packaging preferred)Six Sigma Green or Black Belt certification (preferred) or willingness to pursueOur ExpectationsWe expect our people to be guided by The Amcor Way and demonstrate our Values every day to enable the business to win. We are winning when:Our people are engaged and developing as part of a high-performing Amcor teamOur customers grow and prosper from Amcor’s quality, service, and innovationOur investors benefit from Amcor’s consistent growth and superior returnsThe environment is better off because of Amcor’s leadership and productsEqual Opportunity Employer/Minorities/Females/Disabled/Veterans/Sexual Orientation/Gender IdentityAmcor is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.If you would like more information about your EEO rights as an applicant under the law, please click on the \"Know Your Rights: Workplace Discrimination is Illegal\" Poster. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please call 224-313-7000 and let us know the nature of your request and your contact information.E-VerifyWe verify the identity and employment authorization of individuals hired for employment in the United States.BenefitsWhen you join Amcor, you will have access to a comprehensive benefits and compensation package that includes:Medical, dental and vision plansFlexible time off, starting at 80 hours paid time per year for full-time salaried employeesCompany-paid holidays starting at 8 days per year and may vary by locationWellbeing program & Employee Assistance ProgramHealth Savings Account/Flexible Spending AccountLife insurance, AD&D, short-term & long-term disability, and voluntary benefitsPaid Parental LeaveRetirement Savings Plan with company matchTuition Reimbursement (dependent upon approval)Discretionary annual bonus program (initial eligibility dependent upon hire date)