Quality Assurance Manager
4 weeks ago
Spectrum Plastics Group is seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for ensuring the highest standards are met in accordance with regulatory requirements and/or stated standards (ISO & FDA). Your primary focus will be on 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
- 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
- ISO Certification: 2 years (Preferred)
- Quality Assurance: 3 years (Preferred)
- Manufacturing: 3 years (Preferred)
- Bachelor's (Preferred)
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