Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.
Provides leadership role on championing departmental or cross-functional engineering initiatives.
Provides project direction, coaching, and mentoring for engineering and technical team personnel.
Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
Mentor for technical guidance for identifying and resolving quality issues.
Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Requirements :
5+Years with BS, 3 -4 Years with MS
Ability to take work direction and work independently
Medical device experience
coordination and ownership, communicating with the contract manufacturer and BSC Quality/operations/design teams, supporting design changes activities and supplier corrective records, etc. CAPAPrimary work assignments will be involving supporting our Quality systems and Quality operations for our hepatic artery infusion pump and accessories– authoring post market surveillance report, periodic document reviews,
experiencePost market surveillance
Experience owning CAPA
Root cause analysis experience
Numbers & Facts
Location
Maple Grove, MN
Skills
Analysis Skillsunmatched
Business Solutionsunmatched
Chemistryunmatched
Coachingunmatched
Contract Manufacturingunmatched
Control Systemsunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Documentation Reviewunmatched
Establish Prioritiesunmatched
Infusion Pumpsunmatched
Leadershipunmatched
Manufacturingunmatched
Medical Equipmentunmatched
Mentoringunmatched
Metrologyunmatched
Microbiologyunmatched
Problem Solving Skillsunmatched
Process Control Engineeringunmatched
Product Developmentunmatched
Product Supportunmatched
Quality Assuranceunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Regulatory Requirementsunmatched
Root Cause Analysisunmatched
Software Engineeringunmatched
Surveillanceunmatched
System Operationsunmatched
Team Lead/Managerunmatched
Technical Leadershipunmatched
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