Description
Currently, I am looking to fill a Quality Assurance Manager position in the Twin Cities area with a Medical Device company that boasts a reputation as an industry leader in innovation and operations.The Quality Assurance Manager is primarily responsible for overseeing medical device design, development, validation, and transfer activities. The QA Manager will review and approve product specifications, validation protocols and reports, procedures, and design control documents. This person shall drive the risk management process to assure products meet defined requirements and standards for safety and performance. This person will be responsible for practicing and promoting quality principles throughout the organization and help meet required regulatory compliance requirements.
Essential Duties and Responsibilities:
* Supervise product development teams.
* Lead risk management activities and prepare risk management reports.
* Assure design verification & validation activities effectively prove the integrity of the design & capability of the process.
* Provide audit support and interface with FDA and other regulatory agencies.
* Maintain current knowledge of existing products and technologies as well as competitive technologies.
* Demonstrate leadership and the ability to succeed in managing a team.
* Work collaboratively with other departments, such as R&D, Continuation Engineering and Supplier Quality, to identify and resolve issues.
Education/Other:
* Minimum Bachelor's degree in Engineering, BioEngineering, or related field.
Experience:
* 5-10 years experience in the Medical Device industry.
* Experience leading or managing a team.
* Knowledge of FDA QSR and ISO 13485.
* Solid design verification and/or process validation experience.
* Experience with electro-mechanical devices is a plus.
* ASQ or other quality related certifications (CQE, CQA, CRE, ISA Lead Assessor) is a plus.
Skills:
* Solid leadership and technical competencies.
* Analytical; ability to analyze data and solve complex problems.
* Strong background in quality tools and statistical methods.
* Strong oral and written communication skills. Ability to communicate highly technical information.
* Ability to collaborate across functions while assuring compliance.
* Thorough knowledge of QSR and ISO quality system requirements.
The company will offer a competitive salary and benefits package.
If you feel that you are a good fit for this position, please apply online. Candidates will be contacted in the coming weeks.
IF YOU DO NOT FEEL YOU ARE A GOOD FIT, PLEASE FEEL FREE TO FORWARD THIS TO SOMEONE THAT IS!
To find out more about Real please visit www.realstaffing.com