Quality Engineer, Level II

Elevaris Medical Devices•Wilmington, MA

8d•$90,000 - $102,000

About The Position

The desired candidate will have prior experience working as a Quality Engineer, preferably working in a medical device company. Specific experience and responsibilities will include, but are not limited to, providing Quality and Compliance related support to the manufacture and distribution of medical devices in accordance with applicable medical standards and regulations (ISO 13485, 21 CFR 820, etc.).

Requirements

Bachelor’s degree, preferably in Engineering, Science or Math
2-4 years’ Quality Engineering experience in a manufacturing or industrial environment, preferably in an FDA regulated environment

Nice To Haves

Knowledge of statistical sampling and analysis
Knowledge of ISO, FDA, and QSR concepts and guidelines as well as other national and international regulations and standards
Ability to read blueprints and interpret Geometric Dimensioning and Tolerances (GD&T)
Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (i.e, Six Sigma, Lean manufacturing, etc.)
Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) would be a plus
Excellent organizational, verbal, written communication, and problem-solving skills
Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive, and collaborative manner
Ability to work in a fast-paced environment and to meet tight deadlines
Willingness to learn, possess a can-do attitude, and motivated to succeed and grow
Ability to problem solve, and multi-task with strong attention to detail
Proficient in MS Office Suite, Visio, and Project
Experience working in a start-up environment

Responsibilities

Provide technical support for review and approval of customer complaint investigations
Facilitate Non conformances and MRB activities
Facilitate the execution of Risk Management activities
Identify statistically based sampling plans for inspections and validations
Support validations for new and existing products, processes, and equipment
Ensure compliance with cGMP, QSR, ISO13485, MDD/MDR, and other applicable regulations/standards
Participate in FDA inspections, ISO Registration and surveillance audits and customer audits
Identify and implement opportunities for continuous improvement
Interact and coordinate activities with other departments, external vendors, and customers
Assist or lead in the identification and implementation of CAPA
Aid in the implementation of the SPC control system with Manufacturing and Quality Control
Support internal quality system audits
Provide support necessary for supplier controls, including but not limited to supplier audits
Participate in Post-Market Surveillance (PMS) activities as required
Collect and report metrics and data as required
Upholds and role-models company Values of Integrity, Invested, Inclusion and Ingenuity
Other duties as assigned by management