Quality Engineer, Level II

About the role

Elevaris Medical Devices is a leading manufacturer of made-to-spec procedural needles and a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies, global original equipment manufacturers (OEMs), and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.

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
• Aid in the identification and implementation of CAPA
• Aid in the implementation of the SPC control system with Manufacturing and Quality Control
• 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

Qualifications

• 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
• Preferred Skillset: 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
• Proficient in MS Office Suite, Visio, and Project
• Experience working in a start-up environment

Pay

The Pay Range For This Role Is 90,000 - 102,000 USD per year(Wilmington)