Corporate Quality Engineer (Healthcare focus)

Amcor•Oshkosh, WI

About The Position

Under the direction of the Quality Assurance Manager, the Corporate Quality Engineer ensures compliance with company Quality Management Systems and customer requirements in accordance with ISO 13485, and provides quality engineering support to manufacturing. The role supports quality system maintenance and improvement, manufacturing quality, process and product validation, and audits.

Requirements

Bachelor’s degree in Engineering or Science.
Two or more years of Quality Engineering experience.
Ability to work cross-functionally with Process Engineering, Operations, and Product Development.
Excellent interpersonal and communication skills.
Results-oriented, able to multitask, respond to urgent needs, and meet deadlines.
Excellent organizational skills and ability to work independently and as part of a team.
Strong statistical background and working knowledge of SPC software.
PC proficiency, including MS Office.
Working knowledge of ISO 13485 or ISO 9001 QMSR and FDA Medical Devices Regulations.

Nice To Haves

Quality Engineering experience in medical or food flexible packaging.
Minitab experience.
Six Sigma Green Belt or Black Belt certification, or willingness to pursue certification.

Responsibilities

Assist with process validations (IQ, OQ, and PQ) and product validations according to customer requirements.
Support manufacturing units in analyzing failures and managing preventive and corrective actions related to internal and external issues.
Facilitate Failure Mode and Effect Analysis (FMEA).
Perform Design of Experiments (DOE).
Track, trend, and report quality metrics.
Lead continual improvement activities to enhance the quality system, including 5S and Kaizen lean methods.
Support implementation and ongoing maintenance of statistical process controls (SPC).
Support the engineering change order process.
Assist the Quality Manager in establishing, implementing, and maintaining the quality management system.
Conduct audits, close out audit findings, create audit finding reports, and determine appropriate corrective and preventive actions.
Develop and perform validations, FMEA, root cause analysis, Gauge R&R, and DOE.

Benefits

Medical, dental, and vision plans.
Flexible time off, starting at 80 hours paid time per year for full-time salaried employees.
Company-paid holidays, starting at 8 days per year; amount may vary by location.
Wellbeing program and Employee Assistance Program.
Health Savings Account and Flexible Spending Account.
Life insurance, AD&D, short-term and long-term disability, and voluntary benefits.
Paid Parental Leave.
Retirement Savings Plan with company match.
Tuition reimbursement, subject to approval.
Discretionary annual bonus program; initial eligibility depends on hire date.