Sr Quality Engineer, Regulatory Intelligence.US-HDQ.001 Job at Integra LifeSciences
Overview:
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:
Integra LifeSciences is 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:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
- Act as a lead consultative resource for all compliance matters
- Educate and train on regulations impacting the business, including obstacles to compliance and identification of solutions
- Drive best practices, process enhancements, optimization and continuous improvement efforts based on key learnings from internal and external audits
- Plan, conduct and support internal and external audits from beginning to end to ensure compliance to applicable quality system processes, regulations and standards
- Lead corporate, site and/or functional quality initiatives to promote a quality compliance culture
- Advise and makes recommendations to leadership about compliance issues
- Analyze audit and other compliance data to identify trends and insights to drive proactive quality actions
- Continuously monitor and optimize the quality audit process for improvements
- Coach and mentor new auditors
- Maintain personal competency of applicable QMS regulations / standards
- All other duties and responsibilities as assigned
The requirements listed below are representative of the knowledge, skill and/or ability required for this position.
- Education: Bachelor's degree (at a minimum) in a technical or scientific field
- Certifications: Quality System Auditor (RABQSA, ASQ, etc.) is preferred
- Experience: A minimum of 5 years’ experience working in a quality/compliance environment is required. Experience with cGMP, MDSAP (including FDA regulations such as 21CFR820) and ISO series of quality standards such as ISO 13485 is preferred. Direct experience with FDA and/or Notified Body inspections/audits is preferred. Project management experience preferred.
- Soft Skills: Excellent organization and time management skills is required. Effective verbal and written skills including the ability to collaborate and communicate effectively with all levels of management are required. Ability to be proactive, self-motivated and prioritize and multi-task in a fast-paced environment is required. Strong interpersonal skills, including persuasion, objectivity, assertiveness and thoroughness is required.
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.
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