Ventura Solutions

Associate Quality Engineer

Ventura Solutions  •  Norristown, PA (Onsite)  •  6 days ago
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Job Description

Are you looking for an exciting new opportunity in the Medical Device Space? Take a look at this great entry-level position!

Our client has an immediate opening for an Associate Quality Engineer at their manufacturing facility in Norristown, PA. Under broad supervision, analyze existing processes, develop solutions, and implement new processes to improve efficiencies and labor savings. Manage multiple projects of small to medium scope. Also responsible for day-to-day tasks involving document updates, environmental monitoring, processing SOP updates, supporting complaint investigations, CAPAs, and NC investigations.

Responsibilities

  • Prepare, perform and conduct protocols (i.e. DOE, Process Validation, etc) for new materials and processes. Ensure that new products meet the strict quality and performance standards set by the division (i.e. burst testing, tensile testing, impact qualities, etc.).
  • Perform assignments to enhance existing procedures, statistical analysis, inspections, and validation activities. Contribute to the organization's process improvement activities by participating in Kaizen and other lean events.
  • Support ways to increase operational productivity (i.e. warehouse, manufacturing, reorder, buying and production control).
  • Analyze costs related to capital expenditures to determine breakeven points, payback and associated hard and soft savings.
  • Write functional requirements, test plans, and work with production issues.
  • Conduct training, when appropriate, on quality assurance and/or engineering concepts and tools, including but not limited to inspection, measurement and test methods.
  • Analyze operational procedures to develop; validate; and deploy labor standards (manufacturing related areas).
  • Management may be required including hiring staff, recommending pay increases, conducting performance reviews, training and developing staff, estimating personnel needs, assigning work, meeting completion dates, and interpreting and ensuring consistent application of organizational policies.

Qualifications

  • Requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.
  • No work experience is required!
  • Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary.
  • Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
  • Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations.
  • Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook ).
  • Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting)

Location

  • Norristown, PA

Employment Type

  • Temp to permanent

Benefits

  • Choice of medical, dental, and vision plans.
  • Paid vacation time.
  • Competitive hourly rate.
  • 401(k)

About Ventura Solutions:

Ventura Solutions is a rapidly growing medical device and pharmaceutical staffing, consulting, and training firm. Our extensive industry expertise in medical device, pharmaceutical, and combination products along with an exceptional talent pipeline make us a top choice for a wide range of projects. We also offer great benefits which enable us to attract and retain top talent in the medical device, pharmaceutical, and combination products space. For more information and other job opportunities visit us at ventura-solutions.com

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Ventura Solutions

About Ventura Solutions

Ventura Solutions provides End-to-End consulting, staffing, and training services for the Medical Device and Combination Products industry.

We provide consulting, staffing, and training solutions in the following areas:

-Design Controls

-Risk Management

-Verification & Validation

-Design and Development

-Project Management

-Quality

-Regulatory

-Human Factors

-DHF & Quality System Remediation

-Software as a Medical Device (SaMD)

-Statistics

-Clinical Affairs

-Market Access

-Funding

-NIH SBIR Grants

-Start-Ups

Ventura Solutions is your one-stop shop for getting your product to the market or keeping it compliant.

Detailed list of areas of expertise:

Medical Device & Combination Product Consulting

Design Controls, Risk Management, 21 CFR 820.30, ISO 13485, ISO 14971, Design and Development, Systems Engineering, Project Management, Quality Assurance, Human Factors, IEC 62366, Usability, Design Verification, Design Validation, Statistics, Design History File (DHF) Remediation, Software as a Medical Device (SaMD), Manufacturing, Change Control, Regulatory, FDA Q-Sub, Pre-Sub, Breakthrough Device Program (BDP), Investigational Device Exemption (IDE), 510(k), MDR

Medical Device Start-Up & Business Consulting

Co-Development Deals, Licensing Deals, Fundraising, Non-Dilutive Funding, NIH SBIR Funding, Mergers and Acquisitions (M&A), Commercialization, Valuations, Equity Distributions, Board of Directors, Leadership, Organizational Development, Building High Performing Teams, Concept Evaluation & Selection, FDA or EU Regulatory Strategy, Value Proposition

Staffing, Direct Placement, & Executive Recruitment

Medical Device Engineers, Risk Management Engineers, Systems Engineers, Human Factors Engineers, Design Verification & Validation Engineers; Test Method Development Engineers, Materials Engineers, Project Managers; Process Validation Engineers, Process Development Engineers, Quality Engineers, Design Assurance Engineers, Regulatory Affairs Specialists

Industry
Manufacturing & Production
Company Size
11-50 employees
Headquarters
Vernon Hills, IL
Year Founded
2016
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