Sr Quality Engineer

　　Engineering

　　Little Canada , MN, US

　　Pay Rate Low: 40.54 | Pay Rate High: 46.50

　　Added - 17/01/2024Apply for Job

　　Our client, a global healthcare leader whose portfolio of life-changing technologies spans the spectrum of healthcare, is looking for a Senior Quality Engineer to join their growing team! With an innovative product range from diagnostic and generic medications to medical devices and beyond, you will have the opportunity to grow your career and make a true difference!

　　Pay : $40.50-$47/hr

　　Schedule : M-F 1 st shift (8am-5pm)

　　Type : Contract to hire

　　Requirements:

　　Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred)

　　5+ years technical experience Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies Detailed knowledge of FDA, GMP, and ISO 13485 Solid communication and interpersonal skills.

　　Prior medical device experience preferred.

　　ASQ CQT, CQE, CQA certification preferred Six Sigma root cause analysis/problem solving training and experience preferred.

　　A Senior Quality Assurance Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system.

　　Responsibilities:

　　Accountable for leadership, decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems.

　　Works with and influences key stakeholders to develop and maintain QA procedures, forms, and systems.

　　Develop and lead training for QA systems.

　　Maintain databases and record storage for QA systems.

　　Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.

　　Lead meetings and communications for QA system information, concerns, and updates.

　　Plan for various data storage needs and communicate plans clearly to prevent potential system issues.

　　Lead Global CAPA team with training, CAPA oversight, and CAPA deliverables.

　　Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

　　Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

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　　We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.