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 processesEstablish statistical confidence by identifying sample size, sampling plans and acceptable error, determining levels of confidenceEstablish statistical reliability by using mean time before failure, Weibull distribution, reliability modeling, and reliability demonstration testsAnalyze data by completing hypothesis, normal distribution, and process capability analysis testsPrepare reports by collecting, analyzing, and summarizing data, making recommendationsPerform risk assessment of manufacturing processes to determine the need for and extent of validationManage 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 necessaryRecommend validation needs in relation to cGMP to ensure validation integrityWork with engineering to define and support IQ and OQ validation completion and change control performance measures, and implement subsequent trending for change postmortemDevelop and execute PQ validation protocols compliant to FDA expectations related to product and process conformityEnsure that all validations meet the tenets of applicable regulatory requirementsEnsure compatibility between process capability and Finished Product SpecificationsDevelop and implement short- and long-range goals and plans for continuous improvementRecommend equipment purchase and upgradesDetermine root cause of variability in all key processesAutomated processes / software validationAssist with material improvement to improve process capabilityAssist with site cost savings goals as they relate to qualityAssist production with ensuring that all process trials and experiments are well designed and accurately analyzedSupport generation of reports to verify the process can consistently produce products that meet specificationsEnsure that documented evidence is provided, demonstrating that product can consistently meet release criteriaDevelop site resources in the areas of problem solving and root cause analysisAssist in the summarization of data and creation of summary reports related to Annual Product ReviewAll 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 210-211Desirable Certifications : ASQ Certified Quality EngineerWorking knowledge of FDA Requirements for OTC products as outlined in 21 CFR 210 and 211 and ISO 9001 RequirementsWorking 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 reportsComputer 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 signi?cantly 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 inclusionGreat benefits that start when you do, including an onsite medical clinic available to you and your dependents, 401(k) match, profit sharing, and medical and dental coverage. We also offer tuition reimbursement and an on-site medical clinic!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.
Qualifications
Skills
Preferred
Quality
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Access
Behaviors
Preferred
Dedicated
Dedicated
Team Player
Detail Oriented
Education
Required
Bachelors or better in Engineering or related field.
Experience
Required
5 years : Minimum of relevant work experience in manufacturing with a technical role under FDA 21 CFR 210-211
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.
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