Medical Engineering Consultants (MEC) ยท 4 days ago
Quality Engineer
Arden Hills, MN
Contract
Hybrid
Entry Level
1+ years expMedical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources and expertise to enhance efficiency and productivity. This Quality Engineer role involves investigating product complaints and monitoring product performance data, collaborating with cross-functional teams to ensure patient safety and improve product outcomes.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
Responsibilities
Embodying our client's Core Values of Caring, Meaningful Innovation, High Performance, Global Collaboration, Diversity, Winning Spirit
Reviewing completed returned product, lab analysis, customer feedback and historical data to identify proper coding for product complaints
Performing complaint investigations in accordance with local and global processes
Analyzing post market surveillance data for patterns and trends and investigating when necessary. May be responsible for querying bounding data to support implementation of document releases
Responding to Competent Authority Requests
Communicating product performance by formal presentations to management committees and design teams supporting published product performance reports and customer requests for performance information either directly or through the sales organization
Providing input for process improvement and helping develop tactical approaches to implement team strategies
Perform data analysis for Product Performance and Risk Management documentation by applying statistical methods and software
May be asked to engage in projects/project plans outlining work plans including timelines, roles and resources
Identifies and leads cross-functional project teams comprised of functional experts and local managers
Open and flexible to change in responsibilities taking on new engineering tasks and new product lines as the department grows and evolves
Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
Qualification
Required
BS with 1-3 years of relevant experience
A strong desire to be a part of a team that looks to make a difference each day to collectively solve problems
Understanding and a command of highly technical engineering topics and applied statistics
Ability to independently manage project work to define and consistently meet delivery dates
Understanding and experience operating within quality system processes and procedures
Strengths in communication, verbal and written, and data analysis skills
Preferred
Engineering Degree with 2 years of relevant medical device experience
Strong technical understanding of medical device therapy products
Significant participation in the Hazard Analysis and Risk Assessment as related to trend management
Strong Technical Writing skills
Experience with the quality system escalations, CAPA investigations and field assessments
Strong understanding of the medical device regulatory requirements of post-market complaint tracking, trending and analysis
Project experience and/or collaboration with Medical Safety, Design Assurance, Return Product Analysis, Supplier Development and Manufacturing
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