Manufacturing Quality Engineer

Nice-Pak-posted 21 days ago
Full-time • Mid Level
Mooresville, IN
101-250 employees
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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
  • 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.
  • 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)
  • ASQ Certified Quality Engineer
  • onsite medical clinic available to you and your dependents
  • 401(k) match
  • profit sharing
  • medical and dental coverage
  • tuition reimbursement
  • on-site medical clinic
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