Integra LifeSciences

Manager, Quality Operations

Vacancy ID
2017-23849
MX-JAL-Zapopan
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 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

 

It's a great time to join our growing company and become one of our impassioned colleagues making lives better for the patients we serve!

 

Responsibilities

Serve as the leader of Mexico Quality Operations department and the position is accountable and responsible for the strategic leadership, management and direction of the Mexico Quality functions in Zapopan, Guzman and Flextronics-CMO (Tijuana, MX). Engage and develop a best in-class quality team, ensuring that the organizational structure, talent and resources are aligned with key business imperatives and delivers results with a commitment to excellence and a dissatisfaction with the status quo. Assure the development of targeted short and long-term programs to maximize product quality and availability thereof, and to improve demand planning as a basis for competitive advantage. Provides continuous support, training, mentoring, and development to ensure Mexico Quality performs at a maximum performance level.

 

This leader shall demonstrate business quality acumen and sound decision making by setting direction and making informed, fact-based decisions that enhance quality, financial and operational performance. The Manager, Mexico Quality Operations will apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues and enjoy the challenge of managing a team across a matrix organization.

 

The Manager, Mexico Quality Operations shall create a culture of high-performance and holds self and others accountable and enforces high standards, while demonstrating tact and diplomacy and making difficult or unpopular decisions for the good of the business. The Mexico Quality leader would create an environment in which creativity and innovation are the norm and change is not only accepted but encouraged by championing innovation and change.

Qualifications

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

  • Education:
    • Bachelor's degree in Life Science, Engineering or closely related discipline; Master's degree preferred
    • 8-12 years of Medical Device Managerial experience, including 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
    • Six Sigma Black Belt Certification or other quality related certifications preferred
  • Experience:

    • Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), MEDDEV 2.12-1, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.
    • Demonstrated ability to:
      • build high levels of engagement throughout a plant environment.
      • build a superior leadership team and bench.
      • develop and maintain key internal and external professional relationships.
      • generate results, enthusiasm, high levels of trust, commitment, and a sense of urgency.
      • quickly gain the respect and support of own staff and fellow leaders.
      • build customer relationships with Integra LifeSciences’ partners in order to facilitate strong forecasting, product launch planning, and execution, and to ensure effective customer problem resolution
    • Excellent written and verbal communication skills
    • Excellent organization and interpersonal skills
    • Exemplifies Leadership Integrity and Courage
    • Ability to travel up to 35% of the Time

 


 

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