Sr. Quality Systems Analyst / Complaints

Integra Lifesciences Holdings Corporation Plainsboro , NJ 08536

Posted 2 months ago

Overview

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.

Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra's Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.

Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

Responsibilities

The Senior Quality Systems Analyst is responsible for identifying and applying analytical best practices to Quality System processes across Integra facilities. This person develops metrics and alert limits to facilitate consistent and timely reporting and action in key Quality System processes. This position offers opportunities to partner cross functionally to drive a clear strategy for compliance, provides high visibility and is established as a key position in a high performing team.

  • Lead quality product and process metrics development and reporting for complaints and post market surveillance activities.

  • Lead and continuously improve predictive quality analytics including forecasting, data gathering and modeling.

  • This individual will execute other key projects as required.

  • Leverage new data collection processes to minimize "hands-on" time & reduce collection errors.

  • Communicate product data and trending results to other functional stakeholders (risk management, quality engineering, product development, operations).

  • Work in a team environment with members of Quality on achieving team metric requirements.

Qualifications

  • A minimum of a Bachelor's Degree in a Science/Engineering Mathematics, Computer Sciences or other relevant discipline

  • A minimum of 5 - 7 years of overall experience in the medical device/pharmaceutical industry.

  • Regulatory Affairs Certified (RAC)

  • Quality System Auditor (RABQSA, AQS, etc.)

  • Experience with QSR/GMP (21 CFR Part 820) regulations and ISO (ISO 13485) standards is required.

  • Experience with of 21 CFR Part 11 and Computer/Quality System Software validation, and EU MDR.

  • Strong oral and written communication skills and effective interpersonal skills.

  • Ability to multitask, prioritize and meet deadlines.

  • Proficiency in Microsoft Office (SharePoint, PowerPoint, Word, Excel, Adobe Acrobat, etc.) is required.

  • Experience synchronizing data and preparing presentations for senior leaders

  • Ability to communicate well with all levels of management

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Sr. Quality Systems Analyst / Complaints

Integra Lifesciences Holdings Corporation