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Nice-Pak Products, Inc. · 22 hours ago

Manufacturing Quality Engineer

Mooresville, IN

Full-time

Onsite

Senior Level

5+ years exp

Nice-Pak Products, Inc. is a leading manufacturer of wipes committed to creating a cleaner, healthier world. The Manufacturing Quality Engineer will provide leadership and quality engineering expertise, ensuring compliance with quality standards and supporting continuous improvement initiatives within the facility.

Consumer GoodsManufacturing

Responsibilities

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

Qualification

Quality EngineeringFDA ComplianceStatistical Process ControlISO 9001 RequirementsProblem-Solving ToolsData AnalysisComputer SkillsLeadership SkillsCommunication SkillsOrganizational SkillsAttention to Detail

Required

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

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)

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

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