Description:

Primary Objective
The Quality Assurance Manager ensures compliance to Spectrum Plastics Group (SPG) Core Values, - Safety, Proper and Team while fulfilling the needs of the industry and community. They will direct Niles' Quality department and provide a structured system that requires delivered part quality meets or exceeds customer expectations; ensures compliance to and maintenance of ISO 13485 Quality standard certification; and promotes awareness of customer requirements throughout the Niles facility.

• Quality System Duties:
  • Lead the company’s quality assurance efforts in manufacturing
  • Establish and maintain the Quality Management System (QMS)
  • Maintain certification of the QMS to applicable standards as determined by executive management (e.g. FDA Quality System Requirements, ISO 13485, ISO 9001, etc.)
  • Establish and maintain the internal quality audit program
  • Establish and manage the company’s verification (inspection) activities including quality inspection staff
  • Develop and write QMS documents (procedures, work instructions, forms, etc.) and manage document control staff to publish and maintain the QMS controlled documents
  • Manage resolution of non-conformances including root cause determination, corrective/preventive action (CAPA) plan development and verification of effectiveness
  • Analyze and manage risk, using such tools at FMEA (Failure Mode and Effects Analysis)
  • Perform investigations to determine Root Causes and write reports, as required
  • Perform statistical analysis of processes and product conformance using methods such as Minitab “6-packs” and other statistical tools
  • Receive, respond to, and manage process for resolving customer complaints
  • Perform and coordinate internal and external audits (certification, customer, and vendor audits)
  • Manage a staff of Quality Inspectors and Quality Administrator
  • Work with PPC Wisconsin Plant Converting team as required
  • Conduct and assemble PPAP reports as needed for new products
  • Work closely with Engineering and Sales teams to ensure smooth transitions in new product development process
  • Other duties as assigned

Position Requirements:

• Must have:
  • Proven track record of completing projects in a production environment
  • 2 years’ experience in a manufacturing environment
  • 2 years’ experience in a Quality Management System environment (ISO 13485 or ISO 9001 environment)
  • Experience with Minitab or equivalent statistical analysis software
  • Experience performing Process Capability (Cpk and Ppk) measurements and analysis
  • Experience in writing and managing controlled documents (specifications, work instructions, etc.)
  • Experience working with Corrective and Preventive Action (CAPA) systems and root cause investigation tools and writing reports
  • Experience with ANSI Z1.4 or equivalent inspection sampling plans
  • 2 years’ experience and proficiency in Minitab or equivalent statistical analysis software
  • Strong proficiency in MS Office software including Excel and Word

• Pluses:
  • 2 years’ experience in ISO 13485 environment
  • Six Sigma Green Belt or (preferred) Black Belt
  • Experience communicating with customers and/or vendors and resolving non-conformances
  • Experience with medical device manufacturing
  • Experience with flexible packaging converting, including slitting, web flexography, pouch making, bag making and die cutting.
  • Experience with flexible packaging films
  • Experience supervising production, inspection, and/or engineering technical staff
  • SharePoint experience or willingness to learn
  • Bilingual (English/Spanish or English/Gujarati) preferred

Education Requirements:

• Degree in Engineering or Technical Field
  • Mechanical, electrical, packaging, biomedical, quality, or manufacturing engineering preferred

Qualifications:

• Certified by supervisor to be qualified to perform duties of this job.