Quality Engineer - Medical Devices
Location : Ramsey NJ US 07446
Job Type : Direct
Reference Code : 18921-BZ-MK
Compensation : 75000.00 - 80000.00 USD/YEAR
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Permanent position for a Quality Engineer to review and process complaint records for assigned products.
- Interacting with customers (internal and external) and maintaining associated records.
- Conduct root cause analysis of failed parts including documenting results and compiling records.
- Ensure the integrity and completeness of related complaint files.
- Maintain Quality Analysis Laboratory and associated equipment including creating test fixtures as needed for new products.
- Assist in other quality related investigations where necessary (e.g. CAPA)
- Generate quality metrics and reports as required to support department objectives.
- 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.
- Reviews documentation supporting all aspect of quality related functions.
- Recommends alternative approaches to quality systems and other departmental process.
- Collaborates and considers interrelationships between QA and other functional areas.
- Confidential and sensitive information may be exchanged.
- Interact with Quality Center and R&D teams and must be available for evening conference calls.
- Interacts with regulatory agencies, confidential and sensitive information may be exchanged.
Required Qualifications :
- BS or MS in Engineering.
- Thorough working knowledge of 21 CFR 820, medical device quality systems and processes.
- Minimum 5 years of quality systems related experience.
- Prior experience with FDA audits desired.
- Bilingual (English-Chinese) highly desired.
Contact: Monique Kleiman