Quality Engineer II

The incumbent will review and process complaint records for assigned products which includes interacting with customers (internal and external) and maintaining associated records. Processing may include performing technical analysis of failed parts to determine root cause. The incumbent will support all quality system matters associated including, but not limited to internal/external audits, contract manufacturing, distribution and service-related operations and CAPA.

Essential Functions:

• Ensure the integrity and completeness of related complaint files
• Work with colleagues here and in China to perform root cause investigations on failed product
• Assist in other quality/regulatory related investigations where necessary (e.g. CAPA)
• Support all other quality related operations, as assigned (e.g. project teams, operations support, etc.)
• Identify opportunities to ensure compliance with internal and external quality requirements
• Support internal/external audits
• Support definition and verification of Quality Management Software systems

Decision-Making Authority:

• Reviews documentation supporting all aspect of quality/regulatory related functions
• Recommends alternative approaches to quality/regulatory processes

Position Specifications:

1. Knowledge/Educational Requirements

• Engineering Degree preferred, related field (science, software) considered
• Working knowledge of 21 CFR 820 medical device Quality Management Systems a plus
• 3 to 6 years of Quality Management Systems and/or Regulatory related experience desired

2. Skills and Abilities

• Detail oriented with excellent follow-up skills
• Excellent organizational skills, including the ability to prioritize
• Must be highly self-motivated and be able to work independently with minimum supervision
• Team player with excellent interpersonal skills
• Good problem solving ability
• Bilingual (English-Chinese) desired
• Prior experience with FDA audits desired

3. Physical Demands/Work Environment

• Normal office environment
• Positions Supervised: # Direct Report (0) # Indirect Reports 0

Working Relationships:

1. Internal Contacts

• Frequently interacts with all departments/staff
• Confidential and sensitive information may be exchanged

2. External Contacts

• Interact with MRNA Quality/Regulatory team and Shenzhen Mindray Quality Center and R&D teams; participation in evening conference calls may be required
• Interacts with consultants when directed by Manager

Mindray North America offers an attractive compensation and benefits package plus an exciting professional environment. Only those who meet our requirements will be contacted. Mindray North America is an equal opportunity employer M/F/D/V