A Quality Engineer is needed for a manufacturing company considered one of the world's leading innovators in materials science in the Durham, NC area. This position works closely with other functions within the organization (Manufacturing, R&D, Continuous Improvement, Quality, Engineering, Procurement, and Marketing) and is responsible for the quality of the product and process for the assigned product line(s).
location: Durham, North Carolina
job type: Contract
salary: $32.47 - 47.85 per hour
work hours: 8am to 5pm
- 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 & 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 Project Design History Files.
- Create technical process documents that fit the business needs and maintain compliance to 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.
- Bachelor's Degree
- 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.
- Experience level: Experienced
- Minimum 2 years of experience
- Education: Bachelors
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.