Quality Regulatory Manager
Company: National Biological Corporation
Location: Beachwood
Posted on: May 15, 2022
|
|
Job Description:
National Biological Corporation is the global leader in
FDA-cleared phototherapy devices for the treatment for psoriasis,
vitiligo, and other skin conditions. Founded in 1967 and
headquartered in Beachwood, OH, our products are employed in major
hospitals including the Cleveland Clinic and Mayo Clinic, and
within the homes of patients around the world. National Biological
Corporation is an affiliate of Madison Industries, one of the
largest and most successful privately held companies in the world.
Madison builds entrepreneurially driven, branded market leaders
that are committed to making the world safer, healthier, and more
productive by creating innovative solutions that deliver
outstanding customer value. General Summary: Manager of Quality &
Regulatory will oversee our Quality Management System and lead
continuous improvement efforts in support of our innovative
phototherapy devices and technologies. This role will directly
develop and lead the quality organization and be accountable for
all aspects of quality and regulatory, including quality
engineering, quality assurance, quality control, document control,
training, and internal & external audits, including FDA and
Medicare regulatory compliance. Essential Duties and
Responsibilities: Lead the quality organization, developing direct
reports, and establishing key performance indicators (KPIs) for
each area of responsibility Oversee the Quality Management System,
implementing improvements to ensure patient safety while also
meeting operational productivity goals Maintain compliance with ISO
13485, FDA, Medicare, and other regulatory bodies, conducting
management reviews and leading internal and external quality audits
as appropriate Identify and drive continuous improvement activities
and ensure cross functional alignment Oversee supplier quality,
working closely with procurement to select and quality reliable,
quality-driven partners Work closely with Product Development to
build quality into products and processes Participate in strategic
planning and departmental budget exercises Qualifications:
Demonstrate our core values of Bias for Action, Entrepreneurial
Mindset, and Building Trust Possess a working knowledge of FDA
regulatory and ISO 13485 compliance Have a commitment to good
documentation practices Strong data collection and analysis
capabilities Excellent interpersonal skills and ability to work
with others in a positive and collaborative manner Education and
Experience: Bachelor---s degree in a technical discipline:
engineering, chemistry, biology, statistics, etc. Experience in FDA
regulated medical devices, pharmaceutical, or biotechnology
industries 5 years of Quality Assurance experience An equivalent
combination of education and experience will be considered National
Biological benefits include Health care, Dental, Vision, HSA, FSA,
401k retirement savings with company match, paid time off, and paid
holidays.
Keywords: National Biological Corporation, Cleveland , Quality Regulatory Manager, Executive , Beachwood, Ohio
Click
here to apply!
|