Sr. Quality Assurance Engineer

Confidential Company  •  Billerica, MA

5 - 7 years experience  •  Business Services

Salary depends on experience
Posted on 10/12/17
Confidential Company
Billerica, MA
5 - 7 years experience
Business Services
Salary depends on experience
Posted on 10/12/17

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 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

Responsibilities

The Senior Quality Engineer role provides support to the product development, manufacturing, division and/or corporate site throughout new product introduction.

  • Supports the design, development and transfer of new or improved products/processes
  • Writes and coordinate efforts for the design, development and implementation of new and updated Quality System procedures compliant with applicable regulations and standards, other technical quality documents related to quality planning, validations, risk management, statistical sampling, process control plans, etc.
  • Maintains working knowledge of all applicable standards and regulations
  • Mentors and develops others in the understanding of applicable standards and regulations
  • Promotes the use of industry best practices
  • Drives root cause analysis and process improvemen
  • Uses working knowledge of the application of statistical analysis
  • Partners with cross-functional teams for various product/process projects
  • Exhibits acceptable level of attention to detail

Qualifications

  • Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology), or another closely related discipline
  • Minimum 5 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing,
  • Minimum of 5 years in Quality Engineering
  • Demonstrated experience and expertise creating risk documentation

Preferred requirements

  • Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
  • Demonstrates excellent organizational, verbal and written communication skills
  • Proficient with the MS Office Suite, and statistical software
  • Must be able to work independently with minimal supervision
  • Ability to prioritize projects and manage assigned Quality projects to meet organizational goals and objectives
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