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Quality Assurance Manager

1 month ago

Pleasant Prairie, Wisconsin, United States Spectrum Plastics Master Full time
Job Title: Quality Assurance Manager

The Quality Assurance Manager will be responsible for ensuring the highest standards are met in accordance with regulatory requirements and/or stated standards (ISO & FDA). This includes continuously improving our quality reporting processes, managing the team to ensure quality assurance results are maintained and produced in a timely manner, and controlling, reviewing and challenging our quality associates on customer standards to ensure compliance by providing advice and support.

Key Responsibilities:
  • Responsible for site regulatory compliance
  • Ensure maintenance and implementation of Quality Systems and training
  • Act in conjunction with Plant Manager as technical contact on quality-related issues
  • Address customer concerns, applying root-cause analysis and problem-solving skills
  • Aid in development of suppliers and implementation of Quality Systems Documentation including training documentation and providing appropriate training
  • Lead audits by Third-Party Registrars/Customers
  • Fully support and work with all departments to ensure quality standards are upheld
  • Provide leadership within the daily QA activities and promote a Quality culture throughout the facility
  • Support utilization of ISO and QMS systems cost-effectively
  • Utilize APQP/PPAP, process flow maps, FMEAs, control plans and measurement system evaluations to support Quality Standard requirements
  • Ensure Quality documentation is current with Corrective Actions (PFMEA, Control Plans, Flow Charts, etc)
  • Manage and report key Quality Performance Metrics
  • Work with other disciplines to ensure the integrity of an ISO Class 8 cleanroom
  • Promote company Core Values with key focus on Safety
  • Assist with other various duties as assigned by management
Qualifications:
  • Must possess degree of Science or Business or similar, with 3-5 years' experience in Quality Assurance in a manufacturing environment
  • Must have a thorough understanding and working knowledge of ISO 9001:2015 and ISO 13485:2016 standards
  • Must be a certified Lead Auditor
  • Must have experience managing third party regulatory and customer audits
  • Must have thorough understanding of QA/QC theory, procedures and practices, including potential failure modes for company product lines
  • Must have basic understanding of manufacturing processes and operation systems
  • Must possess strong communication, presentation and analytical skills
  • Must have ability to negotiate and communicate successfully at all levels
  • Must possess strategic planning and development skills
  • Must have extensive knowledge of measuring/test equipment, gauging practices and capability of undertaking full GR&Rs
  • Must possess working knowledge of computers, software applications (at least: Word, Excel, Visio, Access and Outlook) and excellent reading/comprehension skills
Experience:
  • ISO Certification: 2 years (Preferred)
  • Quality Assurance: 3 years (Preferred)
  • Manufacturing: 3 years (Preferred)
Education:
  • Bachelor's (Preferred)