Location: Greater Boston, MA – 100% Onsite
Duration: 12+ months
Start Date: May 22nd or 29th
Title: Quality Engineer (Manufacturing/Operations)
Our Client is looking for a Quality Engineer with Manufacturing/Operations experience. Client is Building a new product at the moment and this contractor will be receiving information both internally and from suppliers. This person will be working with the Design team to develop specs for the team and the suppliers. This will be eventually get to the assembly line at the MA site. The Culture is Fast paced and looking to find someone that needs limited hand holding.
Main skills needed / desired: QA – Test Method Validation, IQ/OQ/PQ, Quality Assurance / Engineering, Medical Devices or Pharma, Project Development (R&D) activities, NCR’s/CAPA’s, Process Validation / Verification, protocol / report writing, V&V Test Methods, Root Cause Investigations, Design Verification – ISO 13485 / 14971, 21 CFR 820
Experience and Education:
B.S. degree, in a scientific, technical, or engineering discipline.
Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements Review, and approve design control deliverables such as requirements, specifications, validation protocols and reports to ensure compliance to customer and regulatory requirements.
Review and approve human factors documentation such as use specifications, task analysis, formative and summative studies protocols and reports.
Support Risk Management activities (RMP, HA, DFMEA, PFMEA, UFMEA and RMR).
Support safety assurance case creation in compliance with the regulatory requirements.
Provides guidance to cross-functional development team(s) in approach to design control documentation.
Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
Support design test and inspection method development, and lead method validation activities
Responsible for establishing, communicating, and mitigating risk throughout the product development process
Participate in design reviews
Performs other related duties and responsibilities, on occasion, as assigned
Other Desired Requirements:
5+ Years of experience in design controls and risk management
Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and ISO 14971
Must possess excellent oral and written communication skills, and the ability to communicate appropriately with cross functional teams
Demonstrated ability to understand and communicate complex technical, statistical and compliance subject matter
Ability to manage and prioritize multiple activities with varying business, compliance and customer drivers.
Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations.
Quality Engineer (Manufacturing/Operations) (233169) Greater Boston, MA