Job Description
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 functionsRecommends alternative approaches to quality / regulatory processesPosition Specifications :
1. Knowledge / Educational Requirements
Engineering Degree preferred, related field (science, software) consideredWorking knowledge of 21 CFR 820 medical device Quality Management Systems a plus3 to 6 years of Quality Management Systems and / or Regulatory related experience desired2. Skills and Abilities
Detail oriented with excellent follow-up skillsExcellent organizational skills, including the ability to prioritizeMust be highly self-motivated and be able to work independently with minimum supervisionTeam player with excellent interpersonal skillsGood problem solving abilityBilingual (English-Chinese) desiredPrior experience with FDA audits desired3. Physical Demands / Work Environment
Normal office environmentPositions Supervised : # Direct Report (0) # Indirect Reports 0Working Relationships :
1. Internal Contacts
Frequently interacts with all departments / staffConfidential and sensitive information may be exchanged2. External Contacts
Interact with MRNA Quality / Regulatory team and Shenzhen Mindray Quality Center and R&D teams; participation in evening conference calls may be requiredInteracts with consultants when directed by ManagerMindray 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