We are seeking an experienced Sr. Quality Engineer to develop and maintain quality engineering methodologies and provide quality engineering support within manufacturing, new product development, or system/services support.
Each employee can make a difference at St. Jude Medical and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
*Impact this role will have on St. Jude Medical:*
* Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
* Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
* Lead, coach, and mentor non-exempt and entry level exempt personnel
* Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
* Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
* Design and conduct experiments for process optimization and/or improvement
* Appropriately document experiment plans and results, including protocol writing and reports
* Lead process control and monitoring of CTQ parameters and specifications
* Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)
* Lead the investigation, resolution and prevention of product and process nonconformances
* Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
* Lead in the completion and maintenance of risk analysis
* Work with design engineering in the completion of product verification and validation
* Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
* *
*Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:*
* BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred
* 5 years experience.
* Engineering experience and demonstrated use of Quality tools/methodologies.
* Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
* *
*Your preferred qualifications and education:*
* Demonstrated supervisory experience
* Solid communication and interpersonal skills
* Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
* Advanced computer skills, including statistical/data analysis and report writing skills
* Prior medical device experience
* Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)
**Job:** **EN-Quality Assurance Engineering*
**Title:** *Sr. Quality Engineer*
**Location:** *Minnesota-St. Paul*
**Requisition ID:** *150000OU*
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