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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

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