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Senior/Staff Quality Engineer

Location:Cincinnati, OH
Exempt/Non-Exempt:Exempt
Employment Type:Full Time
Department:Quality & Regulatory
Description:

The Quality Engineer executes Quality Engineering function for Devicor Medical Products, Inc. and participates in planning, execution and implementation activities for New Product Development and Sustaining Engineering projects. Responsible for compliance programs as it relates to new and existing products.

Duties:

Senior Quality Engineer

  • Improves products through implementations of quality management policies, procedures, specifications, test methods and measurement systems.
  • Develops new and/or improved processes and techniques for engineering tasks.
  • Develops product reliability assessments and reliability test plans.
  • Develops risk management plans, reports, and utilize risk management tools such as FMEAs.
  • Responsible for review and approval of drawings, calculations, specifications and other design inputs/outputs.
  • Provides direction in developing inspection plans, First Article Inspection, In-Process and Final Product Inspection, Sampling Plans, inspection and acceptance criteria and Design Validation Testing.
  • Monitors and/or performs quality activities to support First Article Inspection.
  • Applies sound systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Coordinates and participates in elements of investigations regarding customer complaints.
  • Minimizes customer complaints due to product quality through effective corrective actions and preventative actions.
  • Ensures compliance of project activities to appropriate regulations and standards (FDA, ISO, EN).
  • Partners with Manufacturing, Marketing, Regulatory, and R&D functions to define requirements for new product development.
  • Performs process capability studies or special studies necessary to increase control and lower total quality costs.
  • Uses quality tools and practices to establish approval criteria to ensure the identification of quality failure concerns for both internal and external manufactured parts and assemblies.
  • Supports the validation of product designs, manufacturing processes, equipment, and procedures required for the production and delivery of finished product.
  • Supports the administration of project management and design control.
  • Initiates and directs corrective actions to problems relating to product or process quality.
  • Communicates essential Management Review data to senior leadership such as complaint trending and analysis.
  • Other duties as assigned.

Staff Quality Engineer 

Staff Quality Engineers perform all of the duties described for the Senior Level position with increasing level of complexity and scope.

 

Travel

  • Must be able to travel up to 20% of the time; both domestic and international travel is required.
  • Typical work related travel assignments range 3-5 days, and as such overnight, out-of-town stays are required.

Work Environment And Physical Demands

  • Typical office environment - accommodations will be evaluated where needed.
Qualifications:

Senior Quality Engineer

  • Required - Minimum of 7 years of experience with Quality Engineering in the food, drug, or device industry required.
  • Preferred - Medical device Quality Engineering experience strongly preferred, but not required.
  • Preferred - Supervisory experience strongly preferred, but not required.
  • Required - BA/BS degree in a technical field (i.e. Engineering, Physical Sciences)
  • Preferred - Professional certifications (e.g. CQE) are desirable, but not required.
  • Preferred - Advanced Degree in field is desirable but not required.
Staff Quality Engineer
  • Required - Minimum of 10 years of experience with Quality Engineering in the food, drug, or device industry required.
  • Preferred - Medical device Quality Engineering experience strongly preferred, but not required.
  • Preferred - Supervisory experience strongly preferred, but not required.
  • Required - BA/BS degree in a technical field (i.e. Engineering, Physical Sciences)
  • Preferred - Professional certifications (e.g. CQE) are desirable, but not required.
  • Preferred - Advanced Degree in field is desirable but not required.
General Skills/Competencies/Specialized Knowledge
  • Analytical
  • Communication
  • Interpersonal Skills
  • Presentation Skills
  • Initiative
  • Problem Solving
  • Decision Making
  • Adaptability
  • Trust and Integrity
  • Collaboration and Teamwork
  • Customer Orientation
  • Global/Business Perspective
  • Project Management
  • Motivating Others
  • Negotiation/Influence
  • Leadership
  • Computer Skills


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