Engineer, Sr Quality Job in Maple Grove, Minnesota US
Engineer, Sr Quality
Description Purpose Statement Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality lead for departmental and corporate quality goals and priorities. Provides focused quality review and support for sterilization activities in design assurance, new product development, and operations. Key Responsibilities Provides leadership role on championing departmental or cross-functional initiatives. Provides project direction, coaching, and mentoring for engineering and technical team personnel. Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. Leads in nonconformance, internal and supplier CAPA systems for sterilization. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Performs as quality review and approval role on sterilization documentation. Quality System Requirements In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Qualifications BS degree in related field and 5+ years experience in a regulated industry Must have experience in: Quality system creation and/or maintenance; nonconformance and CAPA systems; and leadership roles on cross functional projects The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.