We are seeking an experienced, high caliber Sr. Quality Engineer. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, 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
* Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirement
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
* 5 years experience
* Engineering experience and demonstrated use of Quality tools/methodologies
* Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
* 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
Your preferred qualifications and education:
* Advanced degree preferred
* Demonstrated supervisory experience preferred
* Prior medical device experience preferred
* Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)
* ASQ CQE or other certifications preferred
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**Job:** **EN-Quality Assurance Engineering*
**Title:** *Sr. Quality Engineer*
**Location:** *Minnesota-Minnetonka*
**Requisition ID:** *150001BJ*
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