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.

About the Job.

Position Title: Quality Engineer
Department: Quality Assurance
Employment Status: Full-time
Classification: Associate
FLSA Status: Exempt

Reporting Relationships:

• Reports to: Manager, Quality

Why This Job is Important.

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.

About You

What You Can Expect.

In this role as Quality Engineer, you could expect to:

• Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes
• Establishes statistical confidence by identifying sample size, sampling plans and acceptable error, determining levels of confidence
• Establishes 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
• Prepares 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.
  • Plan and coordinate the trial process from inception to completion.
  • Support the trials during the execution phase.
  • Create the final trial report at the completion of the trial process.
  • Coordinate any follow-up needed as a result of the trial.
• Support assessment of deviations for the 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 postmortem
• Develop and execute PQ validation protocols compliant to FDA expectations related to product and process conformity
• Ensure that all validations meet the tenets of 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 all 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 that 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 the summarization of data and creation of summary reports related to Annual Product Review
• All other duties as assigned.

What We Expect from You in the Role.

• You must be a champion of Nice-Pak; we protect our people, products, and customers.
• To embrace and embody our Core Values: Safety, Teamwork, Integrity, and Excellence.
• 5 years of relevant work experience in manufacturing with a technical role under FDA 21 CFR 210-211
• Bachelor’s degree in engineering, Science, Mathematics or equivalent experience
• Desirable Certifications: ASQ Certified Quality Engineer
• Working knowledge of FDA Requirements for OTC products as outlined in 21 CFR 210 and 211 and ISO 9001 Requirements
• Working knowledge of Quality Systems and Quality Tools (i.e. Quality Planning, Quality Costs and Assessment, Inspection and Testing, SPC, FMEA, Sampling Principles and AQL)
• Working knowledge of Problem-Solving Tools (i.e, Process Mapping, Risk Analysis, Cause & Effect Diagrams, PDCA, Pareto Analysis, etc.)
• Effectively plan and demonstrate organizational skills, attention to detail, time management, and accuracy.
• Strong Management and leadership skills (i.e. People and Administrative skills)
• Good verbal and written communication skills demonstrated by ability to generate technical reports
• Computer skills and Information Technology (i.e. MS Word, MS Excel, MS Access, MS PowerPoint or equivalent, Visio or equivalent, statistical software usage and principles, Internet/ web surfing, email, MS Project, Database Management)

The non-negotiable things.

• No shortcuts are allowed. We expect you to support our culture of excellence, safety and integrity, and teamwork and hold others accountable for it.
• The law. Nice-Pak adheres to all local, state, and federal laws, and we expect every associate to do the same.
• You will work with many people, so you must be able to communicate respectfully, professionally, and purposefully both in writing and verbally.
• You must be able to read, write, and understand basic math principles, solve problems, and be resourceful on a computer, including Microsoft Office.
• You must be committed to caring for our people – co-workers and customers. This means being a good listener, conducting yourself ethically, providing feedback respectfully, and being honest and fair.

This is what you can count on from us:

• We will provide a safe work environment.
• Working conditions free from unusual hazards or otherwise significantly unpleasant conditions – it usually smells amazing on the production floor!
• We want you to succeed and will invest in you and your career.
• You can count on us to encourage diversity, equity, and an atmosphere of inclusion
• Great benefits, 401(k) match, and medical and dental coverage. We also offer tuition reimbursement.
• Excellent pay, based on experience.

The Important HR and Legal Stuff

Nice-Pak is committed to providing a diverse and inclusive work environment. We are proud to be an equal opportunity employer. We hire the most qualified individuals and do not tolerate discriminatory behavior. We adhere to ADA standards and will review reasonable accommodations to support our employees. Pre-employment screenings, including drug tests, may be conducted as allowed by law.

Apply Now:

If you are passionate about warehouse leadership and looking to make a significant impact, we encourage you to apply and join our Nice-Pak family. Help us continue to provide safe and effective products that improve the lives of people around the world.

#LI-KM1

Experience

• 5 year(s): Minimum of relevant work experience in manufacturing with a technical role under FDA 21 CFR 210-211

Education

• Bachelors or better in Engineering or related field

Skills

• Using database software
• Quality
• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Microsoft Access

Behaviors

• Dedicated: Devoted to a task or purpose with loyalty or integrity
• Team Player: Works well as a member of a group
• Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.