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Quality Engineer

Location : East Rutherford NJ US 07073
Job Type : Temp/Contract
Reference Code : 20446-BZ1
Compensation : open - 45-55/h
Start Date : 02/15/2021
Hours : Full Time
Required Years of Experience : 5
Travel : No
Relocation : No
Job Industry : Medical Devices

Job Description :

  • Contract position for a Quality Engineer Supervisor to ensure timely resolution of quality issues, while continuing to maintain compliance expectations for non-conformances and associated quality records.

  • Reviews and assesses the appropriateness of non-conformance, planned deviation, and corrective action records in accordance with internal procedures.

  • Manage CAPAs in electronic system (document due dates, activities, and promote through workflows and approvals).

  • Plan and lead root cause analysis meetings and develop corrective action plans with content subject matter experts (SME). Implement corrective action plans with support of SME and monitor and verify CAPA effectiveness.

  • Facilitates cross-functional special project teams and acts as representation for QA.

  • Participates in inspections/audits by various regulatory authorities.

  • Serves as QA interface to other departments and/or partners.

  • Lead cross-functional special project teams and acts as representation for QA.

  • Assists in development and maintenance of department Standard Operating Procedures, as needed.

  • Contributes to a culture of continuous improvement through process improvement activities.

  • Supports investigations through guidance of quality workflows, trend queries, and other tools.

  • Contributes to the development, maintenance & reporting of department metrics, as needed.

Required Qualifications :

  • Minimum 5 years experience in Quality Assurance for FDA regulated industry.

  • International experience is a plus.

  • Six Sigma / Black Belt / Lean Certifications preferred.

  • PMP Certificate a plus.

  • Master Control experience is a plus.

  • Working knowledge of FDA Quality System Regulations and Risk Management.

  • Computer proficiency, including web browser/internet search, MS Outlook, Word, Excel, and Power Point capabilities.

  • Technical competence includes the ability to learn new software and systems.

Contact: Bill Zukowsky

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