Medical Engineering Consultants (MEC) · 10 hours ago
(Quality Engineer) Operations
Brooklyn Park, MN
Contract
Onsite
Mid, Senior Level
5+ years expMedical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources, knowledge, and expertise. The Operations Quality Engineer will work closely with customers and the manufacturing team to address problems in Receiving Inspection and manufacturing lines, focusing on continuous improvement and implementing corrective actions.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
Responsibilities
Function as the operation’s quality customer representative when projects are transferred to manufacturing
Supporting design transfer, verification of readiness for production, and ensuring quality requirements are fully implemented
Lead NCMR, customer complaints and CAPA investigation and reports; including trouble shooting manufacturing problems and ensuring compliance to procedures and requirements
Collaborate with suppliers as needed on NCMRs and SCARs, escalating to Supplier Quality Engineering when appropriate
Participate in cross-functional teams for the review and disposition of nonconforming products or components
Participate in cross-functional teams to develop process validation and risk management files, including IQ/OQ/PQ protocols and reports and pFMEA documentation
Review completed Device History Record (DHR) documentation with a high degree of accuracy for Good Documentation Practices (GDP) and completeness
Support and advise project teams on Quality Policies / Procedures (including verification, validation, statistical methods, and manufacturing controls), when necessary
Assist in training of Special Work Orders (SWOs), Receiving Inspection Processes, and First Article Inspections (FAI) as required
Develop and implement error-proofing mechanisms (poka-yokes) to prevent defects and improve manufacturing processes
Assist in internal and process audits; may lead portions of audits as assigned
Qualification
Required
Extensive expertise in manufacturing operations and quality systems in a medical device environment
Understanding ISO 13485 and FDA QSR requirements including root cause analysis, risk management, and process validation
Root Cause Analysis (RCA) includes ability to define problems, collect data, establish facts and draw valid conclusions
Experience in eQMS systems, preferably Grand Avenue Software (GAS)
Experience with error proofing techniques (poka-yokes) and their implementation in manufacturing environments
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
Familiar with the ability to use inspection devices such as pin gauges, micrometers, calipers, pressure gauges, rules and microscopes
Excellent communication skills (written and verbal)
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
Strong interpersonal communication skills with the ability to effectively communicate across all levels
Requires a B.S. degree in Science, Engineering or Technology or associated fields
Working knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971)
Working knowledge of the application of risk management, include pFMEA and process validation
3-5 years' experience in Quality Engineering
5+ years' experience in the medical device industry. Catheter assembly preferred
Preferred
ISO 13485 Lead Auditor certification 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