152 applicants
Medical Engineering Consultants ยท 5 days ago
Process Quality Engineer
Plano, TX
Full-time
Onsite
Entry, Mid Level
1+ years exp
Wonder how qualified you are to the job?
Maximize your interview chancesConsultingMedical Device
Insider Connection @Medical Engineering Consultants
Responsibilities
Support change control efforts associated with the transfer from design to the manufacturing floor for device hardware and software.
Serve as process integrator between the change process and production.
Interpret product and component specifications to support the creation and update of Device Master Record (DMR) and Device History Record (DHR) documents.
Develop and maintain manufacturing and quality documentation, such as work instructions and standard operating procedures.
Identify document requirements, collect inputs from cross-functional technical staff and distill this technical information into detailed, accurate content for assembly and testing documents for nontechnical and technical users.
Ensure compliance with all applicable regulations and standards, including FDA and ISO requirements.
Maintain accurate and organized records of production processes and procedures.
Review assembly processes for definition and implementation of manufacturing tooling and fixtures.
Lead root cause analysis efforts for events such as customer complaints, process discrepancies and supplier issues.
Analyze yield and statistical process control data and propose corrective action efforts for issues that negatively impact the performance of the manufacturing operation.
Apply common engineering principles to identify and quantify improvement opportunities for product and process methodology and consider all aspects of the manufacturing process including manpower, methods, materials, machines, measurements, and the work environment.
Collaborate with cross-functional teams to identify and implement process improvements.
Troubleshoot existing processes and technologies.
Provide direct assistance to the Production Floor for Assembly / Process / Technical issues and work to enhance and simplify documentation utilized by production floor associates in conjunction with the technical functions.
Review and approve BOMs, drawings/labeling (new/modified), specifications.
Develop validation plans and protocols and draft final reports.
Analyze test data using statistical methods
Other duties as assigned
Qualification
Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.
Required
Bachelor of Science degree in engineering or other scientific discipline.
Minimum of 1-2 years of relevant experience in a manufacturing or quality engineering environment, or advanced degree with 0 years of experience.
Communication skills to convey technical matters within the engineering team, with suppliers, manufacturing, and third party test laboratories
Preferred
Understanding of complex, electro-mechanical, software-controlled devices
Good foundation in quality and compliance
Strong understanding of statistical analysis tools.
Familiar with US FDA GMP, ISO standards, as well as comparable international regulatory agency requirements for process and quality control in medical device operations.
Familiarity and understanding of technical disciplines related to Quality Control, Quality Assurance and Validation.
Ability to write and understand technical documents and procedures.
Ability to understand and execute corrective/preventive activities related to product and process control and to perform thorough investigations.
Ability to act effectively as a member of a team to resolve problems.
Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time.
Excellent written and oral communication skills, interpersonal skills and problem-solving skills. Strict attention to detail required.
PC skills to include MS Office Software packages supporting word processing, statistical data analysis, and project management.
Company
Medical Engineering Consultants
Medical Engineering Consultants is a solution provider for medical device and pharmaceutical manufacturers and developers.
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
