Evolved By Nature team is seeking a Senior or Principal Quality Engineer, responsible for driving and supporting all aspects of the quality system, quality through new product introductions, and quality within manufacturing. This position reports into the Senior Director, Quality, and is based in Needham, MA.
Responsibilities:
Actively participate in the product development stage gate process. Lead risk analysis activities and FMEAs, and support verification and validation activities. Ensure quality is built into processes as transferred to manufacturing.
Participates in design reviews, design transfers, and in all aspects of the Design Control process for the new product. Actively participate in and guide all aspects of Design Control and Change Control.
Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements.
Ensure that all work activity is performed in accordance with established internal procedures, and FDA's GMP standards and Quality System Requirements.
Responsible for timely review and approval of batch records, DHRs and batch release.
Lead 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%