Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products.
We have several locations across the US and are looking for new Associates to join our team!
The Quality Engineer will provide leadership and quality engineering expertise to the facility. General duties will include support and facilitate (as needed) trial request process, compliance initiatives for validation, support waste reduction, support deviations, change controls and hold relevant investigations across the plant, support customer complaint reduction efforts through appropriate problem solving tools. In addition, this position will support continuous improvement of an FDA and ISO-compliant quality system that conforms to the Nice-Pak Quality Manual.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
The Quality Engineer will interface with Production, R&D, Warehouse, Management, Supervision, Corporate, sister manufacturing sites in the US and overseas, vendors, and other relevant parties.
• Assess trial requests for the impact on quality, including customer complaints
• Work with appropriate manufacturing team members to ensure:
o Trial request process is followed (operational qualification)
o Review the trial request forms for accuracy as they are submitted
o Upon receipt of Trial Request items, ensure proper involvement from manufacturing and process engineers to determine appropriate line time to execute the trial.
o Ensure appropriate Trial Request information is in place, data collection sheets, materials required (via Warehouse team), and other items not covered by the manufacturing team.
• Work with operations to determine pass or fail achievement and generate final trial outcome reports.
• Support assessment of deviations for the impact on quality as necessary
• Support New Product launch
• Participate in Continuous Improvement initiatives, supports Operational Excellence efforts throughout the facilities
• Support production in investigations of product non conformances
• Lead and facilitate continuous improvement initiatives concerning customer complaints
• Ensure that deviations are in place when needed, provide monthly deviation reports
• Determine root cause of variability in all key processes
• Perform risk assessment of manufacturing processes to determine the need for and extent of validation
• Work with engineering to define validation completion and change control performance measures, and implement subsequent trending for change post mortem
• Manage validation requirements in compliance to cGMP and site mater validation plan.
o Ensure that documented evidence is provided, demonstrating that product can consistently meet release criteria
• Ensure compatibility between process capability and Finished Product Specifications
• Ensure required records are adequately defined, completed and archived.
• Support internal and external customer
• Support line with trouble shooting and investigation to root cause with raw material concerns or defects
• Responsible for impact assessment on validation through the change control process
• Facilitate equipment Factory Acceptance Testing and subsequent Site Acceptance Testing (IQ/OQ/PQ)
• Work with engineering to define new equipment User Requirement Specifications that comply with applicable regulatory requirements
• All other duties as assigned