Sr Quality Engineer

RESPONSIBILITIES:

• Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
• Design, implement, execute, and manage test plans, test cases and test results for Qorvo Biotechnologies LLC products.
• 根本原因分析和实施相关系数ective action for design and process related concerns.
• Interface with Engineering, Operations and Product Management to design and implement appropriate verification methodology and documentation supporting release of products (alpha, beta, final)
• Support the quality inspection to ensure projects, products and processes comply with the relevant requirements of the QMS
• Analyze failure, corrective and preventive action to respond to internal/external customer complaints.
• Create and maintain company quality documentation, such as manuals, procedures, etc.
• Continuously improve QA processes and procedures.
• Preparation of QA reports.
• Oversee quality process at third part manufactures
• Preparation of documentation for submission to FDA for medical device approval and/or response to FDA inquiries.

QUALIFICATIONS:

• Minimum BS/BA in scientific or engineering field
• Familiarity with Grand Ave Software or similar quality system
• 10+ years of experience implementing test strategies, test plans and test cases for software validation and verification in FDA-compliant medical device industry
• Demonstrated success in a start-up, entrepreneurial work environment
• Thorough knowledge of FDA Quality System requirements, ISO 13485:2003 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
• Familiar with EN 60601, Safety requirements for medical electrical systems
• Familiar with ISO 62304, Medical Device Software – Software Life Cycle processes
• 5+ years of experience in verification/validation of diagnostic medical products - point of care experience is a plus.
• 4 or more years of experience with QMS implementation that complies with FDA 21 CFR Part 820, ISO 13485 and ISO 14971 standards
• Lead role (administrative or technical) in one or more FDA submissions for approval of a medical device
• Lead role (administrative or technical) in one or more FDA audits for review of a medical device
• Experience with automated assembly cell manufacturing.
• Experience with Microsoft-based tools.
• Project management skills and proficiency and analyzing and interpreting test data
• Must have previous In Vitro Diagnostic Device (IVD) experience

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MAKE A DIFFERENCE AT QORVO

We are Qorvo. We do more than create innovative RF solutions for the mobile, defense and infrastructure markets – we are a place to innovate and shape the future of wireless communications. It starts with our employees. As a unified global team, we bring a commitment to excellence, growth and a passion for creating what's next. Explore the possibilities with us.

We are an Equal Employment Opportunity (EEO) / Affirmative Action employer and welcome all qualified applicants. Applicants will receive fair and impartial consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, military or veteran status, physical or mental disability, genetic information, and/or any other status protected by law.