Medical Engineering Consultants (MEC) · 6 months ago
Principal Quality Management Systems Engineer
Brooklyn Park, Minnesota
Full-time
Onsite
Senior Level, Lead/Staff
$140/hr - $140/hr
10+ years expMedical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources and expertise to enhance their operations. The Principal Quality Management Systems Engineer will create and update quality system documentation, provide quality engineering support, and ensure compliance with quality management system standards throughout product development.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
Responsibilities
Provide quality engineering support to the project teams to ensure QMS SOP’s are followed and implemented as intended in a consistent manner
Identify and manage risk throughout the development process or assist and coach Design Quality Engineers and ensure risk analysis for all products is completed and maintained using ISO 14971
Coordinate the development of an FMEA when applicable
Participate in the design, development, and prototyping of new devices, components and processes to meet the customer needs, lower costs and improve the quality of the product as required
Assist and coach Design Quality Engineers to design and develop new test methods and equipment
Assist and coach Manufacturing Quality Engineers in creation and improvement of manufacturing processes, process validations, and design transfer
Coach all Quality Engineers related to risk management, statistical methods, problem solving, sterilization and related topics, and other activities
Coordinate, review and approve design verification and validation plans as needed
Review and approve all associated protocols and reports to ensure they meet the intended purpose
Ensure testing is sufficient to meet regulatory requirements and quality objectives
Ensure that deliverable requirements are received, filed and maintained in the DHF/Technical File
Ensure selected design components are qualified per internal documented requirements
Ensure selected suppliers are approved per requirements
Ensure incoming inspection, in-process inspection, quality inspection, and final product test requirements are defined and implemented to the rigor level required per defined risk levels
Manage corrective action activities, when required, and ensure the activities are thoroughly investigated, implemented, effective, and completed in a timely manner
Participate in internal and external quality audits as needed
Review and approve deviations and/or document change requests and generate as needed
Participate in manufacturing transfer planning and implementation
Ensure all finished goods meet established customer and company quality standards
Ensure manufacturing activities are conducted as required and associated paperwork is completed correctly and completely
Ensure all appropriate records are maintained
When needed, author protocols and procedures for the testing, qualification, validation of product and processes
Qualification
Required
Understanding of ISO 13485 and FDA QSR requirements including design controls, manufacturing operations, and risk management
Demonstrated ability to implement, execute, and maintain quality system policies and procedures
Ability to define problems, collect data, establish facts and draw valid conclusions
Highly proficient with MS Office (Word, Excel, Access and PowerPoint), internet and e-mail systems
Solid understanding of software capabilities and business applications
Ability to accurately prioritize and execute with minimal direction
Ability to interpret and understand drawing specifications, tolerances, procedures for inspection and the application of sampling plans
Broad knowledge of theory and principles of statistics and statistical process control
Diverse knowledge of inspection and control methods, techniques and documentation
Excellent communication skills (written and verbal)
Bachelor's Degree in Stem Field
Med Device experience 10 years total, familiarity with Switchback product types preferred
5 -7 of the 10 years of experience in quality, 5 years specifically with QMS development
Creative problem solver coupled with good judgment
Independent work skills
High attention to detail and accuracy
Ability to manage, prioritize and execute multiple tasks
Positive, flexible outlook
Dependable
Strong interpersonal communication skills with the ability to effectively communicate across all levels
Ability to coach and develop personnel
Proven ability to work effectively alone and in a multi-disciplinary team
Presents professional manner and appearance
Preferred
Higher Level Degrees, such as MBA preferred
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