Medical Engineering Consultants (MEC) ยท 4 days ago
Supplier Quality Engineer
Arden Hills, MN
Contract
Hybrid
Entry, Mid Level
2+ years expMedical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources and expertise to enhance their efficiency. The Supplier Quality Engineer will lead performance improvement initiatives for suppliers and collaborate with cross-functional teams to resolve component-related challenges throughout the supply chain.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
Responsibilities
Drives improvement and corrective actions in the quality of components sourced from outside suppliers
Assess, drive reactive as well as proactive supplier projects/investigations partnering with Supplier Engineering Manufacturing/Test operations, Commercial Sourcing, Design Assurance R&D
Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors
Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Has a broad knowledge of a variety of alternatives and their impact on the business unit
Plans and organizes non-routine tasks with approval
Initiates or maintains work schedule and priorities
Plans and organizes project assignments and maintains project schedules
Works under general direction regarding the direction and progress of projects and special assignments
Independently determines and develops approach to solutions
Interprets, executes and recommends modifications to company policies
Assists in establishing departmental policies and procedures
Work is reviewed upon completion for adequacy in meeting objectives
Establishes and cultivates a wide range of business relationships to facilitate completion of assignments
Interacts with suppliers
Participates in determining goals and objectives for projects
May lead projects within the function or department and/or represents a specialized field in larger project teams
Influences middle management on business solutions
Contributes to the completion of specific programs and projects
Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources
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
Assures that appropriate resources, personnel, tools etc. are maintained in order to assure Quality System compliance and adherence to the Quality Policy
Establishes and promotes a work environment that supports the Quality Policy and Quality Systems
Qualification
Required
BS degree in an Engineering related field such as: Mechanical Engineering, Materials Engineering, Chemical Engineering Electrical Engineering or similar technical degree with 2-4 years related experience
Experience in Quality Management Systems, regulatory compliance and risk management
Preferred
Experience with or lead auditor certification to ISO13485, 9001, TS16949 standards
Ability to communicate cross functionally with suppliers team members and leadership
Highly organized and detail-oriented with ability to manage multiple projects and prioritize effectively
Experience with problem solving, quality tools, CAPA, Technical Documentation
Company
Medical Engineering Consultants (MEC)
MEC is a comprehensive solution provider with a full suite of services from consulting and contracting to training and cost savings initiatives.
Founded in 2011Fort Lauderdale, Florida, USA
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Christopher Gustine
Managing Partner
David Campo
Managing Partner
Company data provided by crunchbase