Our client is a mission driven company whose products have a significant impact on human health world wide.
This role supports 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.
Day to Day Responsibilities: • support product team including, Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report functions.
• Facilitate investigations, 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).
• Assist with the investigation of Corrective & Preventive Actions (CAPA), notifications and customer complaints, providing solutions where possible. Communicate customer feedback to Quality Systems group.
• Works with functional groups to ensure changes proposed through the change management program have the proper technical review and that there is a risk assessment of requested changes
- Bachelor’s degree in science, engineer or technical field, preferred.
- Manufacturing quality engineering experience in a highly regulated industry (medical device industry preferred.)
- Capable of the integration and application of user aimed manufacturing process documentation while meeting business and regulatory requirements.
- Demonstrated technical writing skills.
- 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.
- Knowledge of manufacturing processes and relevant statistical methods for quality assurance.
- Good understanding of Continuous Improvement Methodologies, including lean, six sigma, statistical applications and validation.
To apply for this job email your details to email@example.com