170 applicants

Company

Original Job Post

Evolved By Nature · 2 days ago

Principal Quality Engineer

Needham, MA

Full-time

Hybrid

Senior Level

10+ years exp

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BiotechnologyChemical

H1B Sponsorship

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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.

Participate 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 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.

Qualification

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Quality EngineeringQuality ToolsManufacturingProblem-SolvingInternal AuditorLead AuditorMasterControl

Required

Bachelors Degree and 10+ years of related Quality Engineering experience with combination or single use devices (or Master's Degree and 8+years of experience)

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

Preferred

Experience as an internal or lead auditor a plus

Prior experience with MasterControl a plus

Company

Evolved By Nature

Evolved By Nature is a biotech company that focuses on creating Activated Silk technology.

Founded in 2013

Medford, Massachusetts, USA

51-200 employees

https://www.evolvedbynature.com

H1B Sponsorship

Evolved By Nature has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (1)

2022 (5)

2021 (1)

2020 (2)