Integra LifeSciences

Quality Associate

Vacancy ID
2018-25571
Location
FR-Saint Priest
Position Type
Regular Full-Time
Category
Quality Assurance

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 3,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

Responsibilities

Scope: EMEA selling entities: ILS France, ILS Benelux, ILS Switzerland, ILS UK, St Aubin Distribution Center. / CSS and OTT divisions.

Global mission: Under the responsibility of the Quality Assurance manager, the Quality Assurance associate:

. participates to the implementation and the maintenance of the Quality Management System covering all EMEA selling entities cited above in accordance with Corporate guidance and any other necessary standard/regulation (ISO 13485).

. supports all EMEA departments in setting up and deploying harmonized and compliant processes for marketing, selling and distribution activities within the EMEA area. These activities include, but are not limited to launch of new products, acquisitions, new flows of products, all new business project, new software implementation, compliance issues, etc.

 

Responsibilities:

- Quality System:

. Build and maintain the Quality Management System in accordance Corporate guidelines and any other necessary standard/regulation (ISO 13485)

. Manage documents in Agile: (DCO, ECO, MCO / Agile originator, Agile Analyst and Implementation Analyst roles) and notify users through the appropriate way

. Maintain the EMEA training matrix up to date

. Organize and perform Quality Management System training for new arrivals

. Maintain Quality Agreements up-to-date with internal / external manufacturing sites

 

- Product Compliance:

. Perform investigations for complaints related to distribution issues

. Manage nonconformities process

. Keep abreast of current HHE, relay information to the selling entities, and participate to the “Field Safety Corrective Actions” if needed.

. Participate to the CAPA management.

. Movex ERP System: in charge of the Quality items’ reclassification / lot number creation / expiry date completion, and Bill Of Materials’ management in routine

 

- Business support:

. Build and maintain transversal processes for new products, acquisitions, business projects and compliance issues and any organizational changes impacting the Quality Management System.

. Ensure the PMAP process is aligned with Integra policies and Regulatory requirements.

. Collaborate with European and US Quality teams to ensure quality concerns are addressed early in the process and appropriate processes are developed.

 

- Audits:

Perform internal audits.

 

- Others

. Perform all other related duties as directed by management,

. Perform training according to ISO, GxP, Policy, any medical devices or Tissue products regulatory requirements.

Qualifications

. Education: Bachelor’s Degree in LifeSciences, Master in management of Quality

. Type and Number Years of Experience: 1-2 years’ experience in Quality Assurance functions in the health care sector.

. ISO 13485, ISO 9001

. Good documentary practices

. English fluent

. Office pack

. Demonstrated organizational skills

. Sense of initiative, autonomous, priorities

. Project Management, team spirit, good relationship

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