Salary: $100k - 120k per year
Reference: LAC.QA.RA.Mill.12
QA/RA MANAGER
The QA/RA manager will oversee the Regulatory Affairs and Quality Assurance functions. Provides support and makes recommendations to the CEO and senior staff for strategic planning purposes.
A Qualified Candidate will have 10 years’ experience:
- Being the primary interface with FDA, MDSAP and ISO auditor
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Interfacing with engineering in the risk management process
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Working with state, national, and international stakeholders to improve quality and safety of products
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Developing inspection plans, along with Engineering staff, per prevailing standards
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Defining and maintaining process control and equipment calibration
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Making sure processes (including outsourcing) and production adhere to quality standards
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Overseeing of the internal and external audit program
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Analysis of field failures and customer complaints
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Maintaining the Quality Management System, QMS
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Recommending effective corrective and preventative actions
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Developing an integrated, system-wide plan for Quality and performance improvement
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Providing evidence-based recommendations for improving business and manufacturing processes
Required Skills/Education & Abilities:
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Bachelor’s Degree in Engineering, Business, or the Sciences
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Prior experience in ISO certified companies
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Knowledge with ISO: 13485, 21 CFR Part 820
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Knowledge of relevant regulatory requirements
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MDSAP knowledge a plus**
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93/42/Medical Device Regulations and MDR knowledge a plus**
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Experience with FDA Submittals
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Experience with Notified Body Requirements
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Knowledge of Risk Management
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Ability to read blueprints and knowledge of calibration and testing methods
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Knowledge of concepts and methodologies of data analysis and statistical analysis
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Certifications including MDD, MDR, ISO 13485 internal auditor a plus**
Important to know:
- Must be able to work in the US without sponsorship
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Full time position with bonus, benefits
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Competitive Compensation and Benefits based on experience
***For more information on this opportunity or any others, contact Lindsey Croner directly at 605.231.4435**
Resumes may be confidentially emailed to lindsey.croner@gogpac.com
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.
GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.