This contract position is with one of our direct clients. Please reach out to Remya - mremya(at)divihn(dot)com or Pratichi- pjhala(at)divihn(dot)com for more details about this position. You can call Remya-(630)847 7118 or Pratichi- (630) 847 0267. Title: Quality Engineer II Location: Durham, NC Duration: 4-months contract Non-Exempt
Onsite at Durham, NC facility
Summary: Reporting directly to the Quality Engineering Supervisor, this position involves product team support for the manufacturing operations, provides quality guidance, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities.
This position works closely with other functions within the organization (Manufacturing, RandD, Continuous Improvement, Quality, Engineering, Procurement, and Marketing) and is responsible for the quality of the product and process for the assigned product line(s).
Description of Work:
Provide product team support including, Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report functions.
Quality help desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates, and Customer Surveys etc.
Facilitate investigation of Failure Investigation Reports (FIR), Situation Analysis (SA) and Health Hazard Evaluation (HHE) with clear documentation of corrective actions.
Lead discussions on blocked stock and open notifications in Material Review Board (MRB).
Support Life Sciences Corporate (Tewksbury) with Customer Notification Letters from plant projects as needed.
Assist with the investigation of Corrective and Preventive Actions (CAPA), non-conforming product, and customer complaints, providing solutions where possible. Communicate customer feedback to Quality Systems group.
Apply quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, CE Diagram, DOE, MSA, Validation Protocol development, review, approval and Control Plans.
Support Continuous Improvement activities and key plant projects.
Develop/Revise Quality Plans including: incoming, in-process and final inspection, and provide training to those affected by the plans.
Implement proven inspection and metrology improvements and associated training.
Review and approve the Project Design History Files.
Create technical process documents that fit the business needs and maintain compliance with the regulatory requirements of the FDA and ISO standards.
Serve as a resource for performing internal audits to ensure quality system compliance.
Able to react to change and perform other duties as assigned.
Minimum of 2 years of manufacturing quality engineering experience in a highly regulated industry (medical device industry preferred.)
Working knowledge of databases, including Access, spreadsheet applications, Microsoft Project, Minitab and word processing, to perform necessary tasks for preparing required data analysis, reports, documents and general communication.
Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.
Ability to make decisions regarding product disposition and corrective and preventive action effectiveness. Comfortable in giving direction to accomplish assigned tasks.
Knowledge of manufacturing processes and relevant statistical methods for quality assurance, i.e., capable of Six-Sigma skills, certification preferred.
Good understanding of Continuous Improvement Methodologies, including lean, six sigma, statistical applications and validation.
Proficiency in Minitab, Microsoft project, word processing, database, and spreadsheet applications.
Demonstrated technical writing skills.
Thorough knowledge of the regulatory industry requirements ISO13485, Quality Management Systems, Regulation CFR 21 part 820, GDP / cGMP
Six Sigma certification desired.
ASQ Certified Quality Engineer desired.
About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.