Sr. Quality Engineer (#2549)

Responsibilities: 
 

• Cross-Functional Team member to support, procurement, manufacturing and servicing processes representing Supplier Quality Engineering discipline  
• Completes assigned Supplier Quality Engineering tasks to schedule
• Promotes awareness of Quality and Regulatory requirements
• Applies statistical process control (SPC) methods to evaluate current processes and process changes
• Develops new approaches to solve problems identified as part of the team  
• Applies the requirements of the Quality System to processes, products or services for multiple remote locations
• Supports the manufacturing line to address quality issues and resolution
• Using Non-conforming material reports(NCR) and/or supplier corrective action requests(SCAR)
• Supports validation and verification strategy for changes to existing products and processes as assigned
• Participates in the CAPA process as required as an assignee or project team member  
• Investigates escalated product complaints to root cause to ensure timely customer response and correction
• Participates MRB as a team member to ensure proper disposition of non-conformances
• Authors, collaborates, and approves Quality System documentation including change orders, DHF, DMR, DHR, labels and labeling, etc.
• Conducts internal, vendor, and process audits to schedule  
• Interfaces with suppliers to resolve Quality issues  
• Develops and drives measurable Quality improvements relating to products, processes and services

Qualifications:
 

• Bachelor’s degree in Engineering discipline or equivalent  

• Eight plus year’s related experience and/or training; preferably in the medical device industry related to process/quality engineering
• Leadership experience; ability to lead and manage cross-functional teams  
• Knowledge of basic mechanical testing and material properties  
• Knowledge of metrology
• Working knowledge of problem-solving skills, good statistical and analytical skills
• Working knowledge of Problem-Solving Tools
• Working knowledge of Quality Tools (i.e. Quality Planning, Quality Costs and Assessment, Basic Statistic)
• Good verbal and written communication skills demonstrated by ability to generate technical reports, and ability to make presentations to management
• Proficient in the use of Information Technology and applications