US-Scarborough-Maine: Senior Quality Assurance Analyst
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please visit http://sqa.fyicenter.com
Senior Quality Assurance Analyst
• Generates relevant metrics for these processes and reports to management.
• Responsible for lead auditor activities.
• Develop, test and inspect plans; and assures product test requirements align with product performance and labeling claims.
• Develop and generate relevant metrics and trending.
• Maintain product risk files post launch, facilitating FMEAs and other risk evaluation sessions.
• Responsible for ensuring that new products and product .
• Bachelor's degree or equivalent in Engineering, Chemistry, Bio-technology, Life Science or related discipline.
• 3-5 years of experience with a manufacturing company, preferably a medical device or biotech company in a quality or regulatory function.
• Proficient in the use of database, internet, spreadsheet and Word Processing software.
• Working knowledge and experience with FDA cGMPs/QSR, and ISO Quality system requirements.
• Demonstrated understanding of lab practices.
• Quality Auditor Certification (CQA) and Auditing experience preferred
To apply for this position, please visit
Team SQAFYI - Software QA Resource FYI