Manufacturing Quality Engineer

About Us

Nice-Pak is more than just a Nice Place to Work, and we owe it to our amazing team of nice people to ensure we are hiring new team members who can do more than just meet expectations. We aim to hire excellence.

At Nice-Pak, we manufacture products that touch (literally!) a person's every stage of life - from birth through adulthood to retirement - and worldwide! We are a leading manufacturer of wipes for major grocery, discount, drug, big box, and club membership retailers, and we care deeply about our associates and customers. We care about our environment too, which is why we stand by our commitment to sustainably source the materials that make our wipes work and support sustainable forestry through community engagement.

We live by our purpose of Creating Products for a Cleaner, Healthier World and it's important to us that each time we add someone to our Nice-Pak family, we do so with our purpose statement in mind so we can achieve a workforce as special as our customer base.

Position Title: Quality Engineer

Department: Quality Assurance

Employment Status: Full-time

Classification: Associate

FLSA Status: Exempt

• Reports to:
  
  Manager, Quality

The purpose of this position is to provide leadership and quality engineering expertise to the facility. General duties include compliance initiatives for validation and for the implementation of statistical process control in manufacturing and packaging. This position is also in charge of all raw material and process trial planning, execution, and completion. In addition, this position will support continuous improvement of an FDA, and ISO-compliant quality system that conforms to the Nice‑Pak Quality Manual.

The Quality Engineer will interface with Production, Warehouse, Management, Supervision, Corporate Quality, Vendors, and will use support from Compliance agencies.

• Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes
• Establish statistical confidence by identifying sample size, sampling plans and acceptable error, determining levels of confidence
• Establish statistical reliability by using mean time before failure, Weibull 3‑parameter distribution, reliability modeling, and reliability demonstration tests
• Analyze data by completing hypothesis, normal distribution, and process capability analysis tests
• Prepare reports by collecting, analyzing, and summarizing data, making recommendations
• Perform risk assessment of manufacturing processes to determine the need for and extent of validation
• Manage the Raw Material and process trial process, including planning, coordination of execution, final reporting, and follow‑up
• Support assessment of deviations for their impact on quality as necessary
• Recommend validation needs in relation to cGMP to ensure validation integrity
• Work with engineering to define and support IQ and OQ validation completion and change‑control performance measures, and implement subsequent trending for change post‑mortem
• Develop and execute PQ validation protocols compliant to FDA expectations related to product and process conformity
• Ensure all validations meet applicable regulatory requirements
• Ensure compatibility between process capability and Finished Product Specifications
• Develop and implement short‑ and long‑range goals and plans for continuous improvement
• Recommend equipment purchase and upgrades
• Determine root cause of variability in key processes
• Automated processes / software validation
• Assist with material improvement to improve process capability
• Assist with site cost savings goals as they relate to quality
• Assist production with ensuring that all process trials and experiments are well designed and accurately analyzed
• Support generation of reports to verify the process can consistently produce products that meet specifications
• Ensure documented evidence is provided, demonstrating that product can consistently meet release criteria
• Develop site resources in the areas of problem solving and root cause analysis
• Assist in summarizing data and creating summary reports related to Annual Product Review
• All…