Senior Quality Assurance Engineer
1 week ago
Role: Senior Quality Assurance Engineer
Location: Rockford, IL
Duration: Fulltime
Job Description:
- Engineering Graduate with 10+ Years of experience in Process Quality and Operational Excellence
- Strong understanding of Process Quality Assurance aligned with ISO 9001:2015, CMMI V2.0 and AS9100D.
- To ensure the effective implementation and maintenance of quality management system as per the applicable regulatory/standard requirements
- Report top management on the effectiveness of the quality management system and any need for improvement
- To ensure the awareness of customer requirement, applicable regulatory requirements and quality management system requirements throughout the organization
- To organize and conduct Management review meetings
- To liaison with Notified body, regulatory authorities or competent authority
- Responsible to prepare, review, approve, implement and maintaining of quality management system and update of the Quality Policy, Quality Objective and Quality Planning as per the applicable regulatory requirements
- Organizing and conducting Internal Audits and External/Supplier Audit, and preparation of Audit reply and plans
- Responsible for Document & Record Control.
- Responsible for Release, Change and CAPA Management
- Ensure structured initiation of projects and identify risks at the outset
- Ensure appropriate processes and plans are established to ensure first time right delivery
- Analyze the internal review outcomes and drive process improvements & trainings
- Sustain and ensure compliance to org certifications; support and facilitate external assessments like ISO 9001, EN9100 etc
- Drive/ Support the Business Unit / Team specific initiatives, as required
- Promote the use of best practices
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