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Senior Quality Assurance Manager
2 months ago
Evolved By Nature is seeking a Quality Engineer to drive and support all aspects of the quality system, quality through new product introductions, and quality within manufacturing.
Key Responsibilities:
- Participate in the product development stage gate process, leading risk analysis activities and FMEAs, and supporting verification and validation activities.
- Participate in design reviews, design transfers, and all aspects of the Design Control process for new products.
- Support the Quality Policy by building quality into all aspects of work and maintaining compliance to all quality requirements.
- Ensure all work activity is performed in accordance with established internal procedures and FDA's GMP standards and Quality System Requirements.
- Review and approve batch records, DHRs, and batch release in a timely manner.
- Lead the MRB team to ensure timely disposition of planned deviations and nonconforming material.
- Manage and support team with CAPAs and complaint investigations.
- Manage deviations through their life cycle and review trends for corrective actions.
- Mentor and provide guidance to peers and quality team members on best practices.
- Support activities associated with agents of regulatory bodies as necessary to demonstrate quality system compliance.
- Support certification/recertification activities for US, European, and other markets.
- Serve as an Internal Auditor to support the quality internal audit program.
- Develop and establish effective quality plans.
Requirements:
- Principal Quality Engineer: 12+ years of related Quality Engineering experience with FDA regulated products.
- Senior Quality Engineer: 7+ years of related Quality Engineering experience with FDA regulated products.
- Bachelor's degree in Chemical Engineering, Industrial Engineering, Process Engineering, Biomedical Engineering, or a Science field.
- Proven proficiency with quality tools and techniques in a manufacturing environment.
- Experience with Food and Supplements GMP standards a plus.
- Experience with MasterControl a plus.
- Experience as an internal or lead auditor a plus.
Skills & Abilities:
- Strong attention to detail.
- Strong written and verbal communication skills.
- Strong problem-solving skills & techniques.
- Well-versed with ISO 13485 and FDA QSR standard.
Travel Requirements:
Up to 10%
