QA Specialist IV
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POST DATE 8/31/2016
END DATE 12/7/2016
JOB DESCRIPTIONAPPLY Job Description
What you ll be doing:
* Provide QA Support to manufacturing operations in the areas of change control, validation, nonconformance and CAPA
* Support external, internal and supplier audits
* Perform training on Quality System regulations
* Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR, IVDD and ISO 13485
* Certified Lead Auditor with medical device focus a plus
* Full working knowledge of investigational techniques and risk analysis
* Serve as QA team member on product development projects to ensure compliance with design controls
* Advise, evaluate and approve protocols, reports, and SOPs to ensure compliance with internal requirements as well as to standards/regulations for worldwide distribution
What you need for this role:
* BS degree in a science related field
* 7+ years working in a FDA regulated industry, preferably medical device/IVD. Successful track record of collaboration with manufacturing and other cross-functional departments
* Prior manufacturing or analytical experience a plus
* Strong interpersonal skills with the ability to build cross functional relationships
* Must be self-motivated with the ability to work as a team player and/or independently
* Advanced problem solving and communication skills.
* Knowledge of chromatography, immunoassays and manufacturing operations a plus
What s in it for you:
* Competitive pay and great benefits including medical, dental, vision, 401k and more
* Opportunities for growth and training
* Stability of a profitable 60+ year old company
* Great work environment
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age Employer
To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.