Senior Quality Engineer II
Senior Quality Engineer II
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Job Description
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us change equals opportunity. Every day more than 4000 of us are challenging whats possible and making headway to help improve outcomes.
Oversees the of the quality plans ensuring product realization is conducted in compliance with internal customer and regulatory requirements during all phases of the product lifecycle.
Under limited supervision and in accordance with all applicable federal state and local laws/regulations and Corporate Integra Lifesciences procedures and guidelines this position will include:
Product Design and Manufacturing Review: Evaluate new and modified product designs and manufacturing processes to ensure they meet quality standards including manufacturability serviceability testability reliability and compliance with product and quality system requirements.
Risk Management: Oversee the product risk management process including the creation maintenance and update of risk management files to ensure product safety and compliance.
Supplier Qualification and Audits: Qualify component and service suppliers perform supplier audits and ensure proper supplier quality controls are in place to maintain product quality.
Data Analysis Statistics and Continuous Improvement: Analyze data and apply engineering principles to drive continuous improvement projects ensuring product and process quality are optimized.
Statistical Application: Utilize statistical methods in new product development and continuous improvement initiatives to ensure robust and reliable outcomes.
Crossfunctional Collaboration: Provide expert guidance to R&D Operations and Quality teams on design controls production and process controls risk management root cause analysis validation and the application of statistical techniques.
Compliance Monitoring: Stay updated on internal and external changes to quality engineering standards and regulations and develop strategies to ensure compliance across all areas.
EXPERIENCE AND EDUCATION*
Required:
Bachelors degree in engineering physical science statistics or related discipline
At least 4 years of experience as a quality professional in a regulated industry
Indepth knowledge of design control risk management production and process controls and applicable regulations (i.e. ISO 13485 FDA Quality System Regulation ISO 14971
Working knowledge of and experience in the application of statistical methods
Excellent verbal and written communication skills
Preferred:
Advanced degree in engineering physical sciences statistics or related discipline
Process Excellence/Six Sigma certification
ASQ Certified Quality Engineer (CQE)
Required Experience:
Senior IC
Employment Type
Full-Time
