Quality Engineer II

Job Description

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

Full-time