Senior Director Global Product Quality

Company: Integra Lifesciences
Location: Princeton
Posted on: June 24, 2022

Job Description:

Senior Director, Quality Assurance and Compliance - TT Division Vacancy ID 2021-40253 Location US-NJ-Princeton Position Type Regular Full-Time Category Quality Assurance Overview Integra LifeSciencesis a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we've evolved into one of the world's leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.
But that's just the beginning.Integra is growing at an unprecedented rate. We're at a moment in time where the experience you'll gain is more robust than the experience you bring. And we're out to invest in your future because it's the best way to maximize ours. At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra's ongoing commitment to our values and our shared success. Integra's health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both. Regardless of geographic location, our commitment is to offer the following, whenever possible:

• Benefit plans that meet all local statutory requirements
• A range of programs that reflect typical local market practices
• An opportunity for employees to tailor benefits to their specific needs
• Benefits that balance employee's short-term and long-term needs Click HERE for more information regarding our benefits and total rewards program Responsibilities Directs, coordinates and evaluates the activities of employees in the Quality Department, including Quality Assurance, Quality Engineering and Quality Control. These activities include the development, implementation, and monitoring of quality programs and policies that ensure the development, manufacture and distribution of medical devices in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical Affairs Law, Anvisa, TGA and AATB, ISO 2242 and other applicable regulatory agencies.
  • Directly supervises employees in the Quality Department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
  • Builds high performance cultures and teams, empowering and holding direct reports and cross-functional teams accountable for successful implementation and execution of CAPAs, continuous improvement initiatives, and other quality initiatives
  • Provides strategic direction and communication of the company's goals, directives and policies to subordinates, creating a clear vision and positive, team-oriented environment resulting in the achievement of the company's goals and increased profitability.
  • Oversees TT manufacturing quality and drives standardization & consistency across the Division
  • Ensure dependable and timely results from quality control, including process control and support for process changes in compliance with QSR, ISO and other regulatory requirements.
  • Ensure and improve product reliability through proven quality science. Post market surveillance, CAPA, Complaints, reduction of nonconformity.
  • Oversee product quality reviews, divisional management reviews and preparation of quality reports as applicable for various forums, Divisional Board Review (DBR), Plant Operational reviews etc.
  • Direct the activities of the Quality Department to ensure compliance with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, MDR and JPAL.
  • Ensures site compliance and readiness. Oversees external regulatory inspections, timely follow up and closure of Regulatory commitments.
  • Interact and coordinate activities with other departments, external vendors and customers. Influences and collaborates across stakeholder groups in the areas of process / continuous improvements, identify and implement opportunities.
  • Ensure that all projects and validations are in compliance with QSR, ISO and other regulatory requirements.
  • Participate in evaluation of new product opportunities (introductions, enhancements, obsolescence).
  • Maintain fiscal responsibility and budget compliance.
  • Perform other related duties as expected. Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
    • High educational background/Master in a scientific discipline required with min 15 years experience in the medical device or pharmaceutical industry and minimum 7 years of people management experience.
    • Strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.
    • Significant area of expertise developed through experience and positive track record.
    • Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, Medical Device Regulation, Japanese Pharmaceutical Affairs Law, and other national and international regulations and standards.
    • Experience with direct contact with FDA and EU Notified Bodies.
    • Knowledge of process design and implementation, change control, auditing, and document management systems.
    • General knowledge of statistical analysis.
    • Demonstrated organizational, management and communication skills.
    • Must be able to read and write in English. Must be able to demonstrate comprehension of written English by successfully completing unassisted written tests, including, but not limited to, Work Instructions and Standard Operating Procedures.
    • Ability to travel up to 30% or more if needed base on site needs. In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law. Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.

Keywords: Integra Lifesciences, Trenton , Senior Director Global Product Quality, Executive , Princeton, New Jersey