Medical Engineering Consultants (MEC) ยท 7 hours ago
Quality Engineering Manager (Medical Device)
Brooklyn Park, MN
Contract
Onsite
Senior Level, Lead/Staff
8+ years expMedical Engineering Consultants (MEC) supports medical device and pharmaceutical companies by providing resources and expertise to enhance productivity. The Quality Engineering Manager will oversee Operations Quality Engineering personnel, manage the NCMR system, and collaborate with teams to address manufacturing issues and ensure compliance with quality standards.
ConsultingMedical DevicePharmaceuticalTraining
No H1B
Responsibilities
Manage, mentor, and coach Operations Quality Engineers on quality standards and best practices. Provide job direction, training and conduct performance reviews
Manage the NCMR system in Grand Avenue (GAS) including tracking and trending NCMRs to identify CAPAs as required
Communicate nonconformance issues across all levels of the organization
Lead CAPA Investigations and implementation of corrective actions to ensure thorough investigation, effectiveness and timely completion
Manage manufacturing quality problems through systematic root cause analysis, data-driven decision making, and cross-functional collaboration
Create Master Validation Plans for processes transferring to manufacturing
Support process validation activities including protocol development, execution oversight and report approval
Identify supplier issues and drives improvements to reduce incoming non-conformances
Manage supplier quality relationships and facilitate corrective action implementation as needed
Conduct supplier and process audits as needed to ensure compliance with quality standards and regulatory requirements
Implement Statistical Process Controls (SPC) on production lines to monitor process capabilities and drive continuous improvement
Develop and implement error-proofing mechanisms (poka-yokes) to prevent defects and improve manufacturing processes
Support risk management activities in accordance with ISO 14971, including participation in pFMEA creation and updates
Maintain and oversee content of the Device Master Record (DMR) to ensure accuracy and compliance
Audit Design History File (DHF) for completeness and accuracy
Support internal and external audits, including client audits conducted on the Operations level
Participate and lead response to audit findings
Qualification
Required
Extensive expertise in manufacturing operations and quality systems in a medical device environment
Deep understanding of ISO 13485 and FDA QSR requirements including design controls, risk management, and process validation
ISO 13485 Lead Auditor certification
Experience conducting supplier audits and process audits
Experience in eQMS systems, preferably GAS
Experience with error proofing techniques (poka-yokes) and their implementation in manufacturing environments
Root Cause Analysis (RCA) including, 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
Familiar with the ability to use inspection devices such as pin gauges, micrometers, calipers, pressure gauges, rules and microscopes
Broad knowledge of theory and principles of statistics and statistical process control
Excellent communication skills (written and verbal)
Ability to lead cross functional teams and influence without authority
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
Bachelor Degree in engineering or a related STEM field is preferred. Equivalent work experience or MBA may substitute
Minimum of 8+ years experience in Quality Engineering Operations in a medical device manufacturing/process development environment
Minimum of 3+ years leading a team of engineers and/or technicians
Experience in process design development and product development team environment
Experience in a manufacturing team environment. Catheter assembly 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