Quality Engineer II

*** Candidate needs to be familiar with med device industry and its quality regulations. Pay rate: $50.75/hr.

This role will support investigation of products related to complaints and monitor product performance. This engineer also creates metrics and detailed slides related to product performance of fielded products and present the results to other functions and upper management.

Key Responsibilities

• Provides Quality Engineering support:
• Collects, analyzes and trends complaint data for other groups including upper management
• Helps in analysis and deeper dive into escalated monthly trends
• Presents the data to upper management in meetings
• Creates dashboard views in tools such as PowerBI to help with analysis and monitoring of complaint trends
• Plans validation of analysis reports/dashboards and executes the validation
• Works with members of operation/mfg, R&D, risk management and design assurance to resolve quality issues related to product in the field
• Collaborates with R&D to understand new failure modes seen with field return products
• Creates, revises, and approves departmental procedures in electronic document control system (Windchill)
• Maintains test equipment inside Complaint Investigate Site's lab
• Initiates, owns and completes NCEPs/CAPAs in electronic NC system (eCAPA)
• Trains technicians or more junior engineers in the lab on how to troubleshoot field return samples and on other lab processes
• Proactively investigate, identify, and implement Quality System improvements
• Provide leadership role in championing departmental or cross-functional engineering initiatives
• Provide direction, coaching, and mentoring for technical team personnel

Quality Systems Duties and Responsibilities:

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications

• 2 - 4 Years of work experience with BS, 1 - 2 Years with MS in a technical field
• Proficient in data analysis and data-view/dashboard creation using tools like PowerBI and Excel
• Ability to process, manipulate and analyze failure/complaint data to look for patterns, failure rates, etc and to create charts & reports for management review.
• Strong knowledge of MS Excel (advanced user) and PowerBI.
• Working knowledge of SAS, Oracle and other database structure and programming languages (intermediate user) is highly preferred.
• Great verbal/written communication skills
• Technical ability to investigate medical device field failure returns.