Please send all resumes to jobs-vasonova@teleflexmedical.com.

POSITION TITLE: Quality Engineer

DEPARTMENT: Quality Engineering/Quality Assurance

PURPOSE: To provide effective Quality Engineering during design development, Manufacturing process, and Distribution; analyze field failures, in-process failure and initiate corrective action steps, and to provide customer liaison on major technical problems.

REPORTS TO: Director Quality Assurance

QUALITY IMPACT: Ensures that Quality Engineering activities are conducted and documented in accordance with appropriate industry and regulatory standards and Company Procedures and Policies.

DUTIES/RESPONSIBILITIES:

  • Performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products.
  • Quality Engineering for New Products for; FMEA, statistically acceptable verification and validation protocol’s, guide team through Design Control, necessary quality, reliability, and maintainability design constraints and design evaluation criteria using appropriate statistical methods.
  • Evaluates the effect on reliability of shelf life, storage, handling, and shipping.  Provides input to logistic plan and packaging requirements.
  • Provides an effective product acceptance function.  This includes specification based inspection instructions, performing gauge R&R’s, test method validation, documentation requirements, specifications compliance requirements, flow charts, first article criteria, and AQL sampling plans as required.
  • Reviews and approves all test procedures to ensure compliance with all specified requirements.  Clarifies instructions and ensures conformance to the program test plan.
  • Provides coaching and mentoring in Design Control, QSR, MDD, and ISO 13485 requirements
  • Determines cause and required corrective action on the part of organization (i.e. vendors, customers or departments) responsible for cause. Maintain status and follow-up for all required actions.
  • On a program basis, reviews and analyzes the overall results of complaints and corrective action system to ascertain a measure of achieved reliability.
  • Provides feedback to suppliers with NCR and in process data.
  • Chart Manufacturing Critical to Quality variables using various SPC methods
  • Analyzes inspection and test results for deficiencies in Manufacturing, IQC, Customer Complaints.  Initiates corrective action as required and provide summary reports for management use.
  • Reviews and dispositions change notices (ECO/MCO).
  • Prepares quality, environmental, and reliability test specifications and procedures, and maintains demonstration plans. Conducts the performance of all such tests, utilizing the services of Engineering and Environmental Labs as required.  Evaluates the results and prepare necessary reports after completion.  Provides customer liaison as required throughout the preparation and performance of these tests.

POSITION REQUIREMENTS:

EDUCATION:

  • Bachelor of Science degree

EXPERIENCE AND TRAINING:

  • Minimum of three to five years experience in a QA function
  • Six Sigma Green Belt Black Belt a plus or strong statistical background
  • Demonstrated experience in implementating the FDA, QSR, ISO (specifically Design/Process Control and Process validation is required) and the MDD
  • Ability to develop strong cross functional relationships between QE/QA, R&D, Manufacturing and Marketing.
  • Proficient in Microsoft Excel, Word, Project, PowerPoint, Visio, MRP (Mfg.pro)
  • Able to manage multiple projects, Base Business and meet agreed upon deadlines

 

Title: Incoming Quality Control (IQC) Inspector

General Responsibilities:

This position reports to the Director of Quality Assurance. They are responsible inspecting incoming raw materials and subassemblies for conformance to applicable drawings and specifications. Parts for inspection include mechanical, electrical components, labels, chemical, printed material and potential biohazards components.

Specific Responsibilities:

As a member of the Quality Assurance Team, the desired candidate will:

  • Perform and process first article inspections
  • Correlate supplier’s first article inspection report with VasoNova first article inspection results.
  • Inspect incoming and production subassemblies as needed
  • Maintain inspection documentation in accordance with VasoNova SOPs, WIs and appropriate forms.
  • Write and close non-conformance reports as needed.
  • Prepare non-conformance reports when appropriate.
  • Work with the director for Material Review Board (MRB) meetings
  • Interface with Engineers on new product development component inspections and non-conformance results.
  • Monitoring receiving inspection Backlog and though put.
  • Work in the clean room to perform both in process and final catheter inspection

Education and experience

The profile of the desired candidate will include:

  • High School Diploma or equivalent
  • 5-9 years experience working in Incoming inspection, or related field
  • Basic math and communication skills.
  • Experience working at a medical device or aerospace company.
  • Inspect components utilized microscope
  • Experience using calibrated hand measuring tools, e.g., calipers, micrometers, scales (ruler), precision pins, precision gauge blocks.
  • Knowledge of GMP & ISO compliances.
  • Understand sampling procedures / standards and tables (i.e. C=0 & ANSI)
  • Must have good computer skills (Microsoft Word, Excel and other software packages)
  • Must be able to interpret mechanical component and assembly drawings & specifications
  • Smart scope automated inspection machine (nice to have)
  • Excellent attention to detail