Engineer Quality

VIVOS HOLDINGS•Mooresville, IN

About The Position

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.

Requirements

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
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)

Nice To Haves

Desirable Certifications: ASQ Certified Quality Engineer

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.