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Job Openings >> Quality Engineer
Quality Engineer
Summary
Title:Quality Engineer
ID:1695
Department:Quality
Location:Wolcott, CT
Description

Position Summary:

This position is responsible to assure that quality and manufacturing processes comply with the product specification, customer requirements, and regulatory/government agencies requirements.  Control total quality and establish ways of evaluating the quality of products. Responsible to develop, modify, apply, and maintain, standards for quality operating methods, processes, systems, and procedures and ensure compliances to corporate and regulatory requirements including ISO 13485 standards.

Essential Functions and Basic Duties:

  • Lead and document investigations for corrective actions, customer complaints and nonconformance. 
  • Support product development activities i.e. DFMEA, PFMEA, PCP, PVP, TMV, and validation protocol reports IQ, OQ, PQ.
  • Lead cross functional teams to improve process and product understanding.
  • Assist in determination and implementation of test and inspection activities required for quality inspection.
  • Resolve customer quality issues by executing Corrective Action Preventive Action (CAPA) processes.
  • Implements process improvements including fixtures, tooling, production checks, testing/inspection devices.
  • Establish mechanism to evaluate, measure, monitor and/or quality in our products to improve efficiency of the production process.
  • Review and approve product design.
  • Act primary contact in internal/external audits to ensure the effective implementation of Quality Management System (QMS)

Qualifications

Education / Certifications:

  • Bachelor’s Degree (BA) from a four-year College or University

Required Knowledge/Experience:

  • Minimum 5 years’ experience in QE capacity engineering in a manufacturing environment; preferably in a medical or pharmaceutical environment.
  • CQE preferred.
  • Working experience with the application of statistical methods in quality assurance systems and processes. 
  • Six Sigma Green Belt Certification preferred.

Skills/Abilities:

  • Strong written and oral communication skills.
  • Excellent organizational and interpersonal skills.
  • Knowledge of 21 CRF 820 and cGMP’s
  • Ability to develop sound and simple systems to assure ISO and regulatory compliance.
  • Well-developed verbal, numerical reasoning and analysis sills with ability to draw sound conclusions. 
  • Ability to interact with operations management at all levels including off-site management.
  • Ability to take initiative; completion of tasks in an accurate and timely manner; attention to detail.
Great benefits offered including medical, dental, 401K and more!

Biomedical Innovations is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, Biomedical Innovations will provide reasonable accommodations for qualified individuals with disabilities.
This opening is closed and is no longer accepting applications
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