Quality Assurance Engineer

Job Description

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Quality Assurance Engineer for a 18 month + Contract .

Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

Position Description (Principle Duties and Responsibilities) The purpose of this position is to work within the quality operations team, under minimal supervision, with responsibility for quality related activities and to assist in the implementation, evaluation, and maintenance of a comprehensive and effective quality and regulatory program that complies with FDA regulations, ISO requirements, and other applicable regulatory bodies or standards.

Essential duties & responsibilities : ·Work closely with operations and the business functions to ensure quality performance of product and processes.

• Collaborates with Divisional QA, cross-functional and supplier's teams to address top quality issues. ·Own identified internal and supplier driven non-conformances and manage the timely closure of NC's within.
• Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure. ·Disposition non-conforming product within MRB, issuing NCs as appropriate.
• Communicate with suppliers regarding non-conformances, escalating supplier corrective action requests as required. ·Engage in the development and improvement of the internal manufacturing processes for existing products.
• Performs critical assessment of internal and supplier proposed change management activities. ·Participates in the creation and / or review of new or modified procedures.
• Maintain KPIs for monitoring of process and / or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
• Support execution and analysis of manufacturing related complaints and product field actions. ·Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
• Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification. ·Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.
• Support the creation and maintenance of inspection methods and sampling. ·Applies statistical methods of analysis and process control to current operations.
• Engage and interface in internal and external audits providing subject matter expertise. ·Support the development and review of process and equipment validation / qualification and MSA of internal processes.
• Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier initiated changes.
• Support manufacturing transfers to / from other plants / facilities, executing appropriate quality activities. ·Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes.

Job Requirements

Education & Special Training

• Bachelor's degree required; degree in Engineering discipline preferred; Biomedical, Process, or Mechanical Engineering recommended. Qualification & Experience
• Minimum of 3-5 years' experience in a quality role for a medical device company; this requirement may be satisfied through equivalent experience obtained from any technical role within a regulated manufacturing environment
• Ability to read and interpret engineering drawings and other technical specifications preferred
• Knowledge of Quality Concepts (. Risk Management, CAPA, Audits, Statistics)
16 days ago