Quality Assurance Technician - Apollo Professional Solutions

Quality Assurance Technician
New Haven CT
Contract - 1st shift, 5/40
Pay Rate:  $41.38/Hr.
Benefits:  medical, dental, vision, 401k

Requirements:  Quality Assurance Technician

• US Citizenship
• Experience in design control activities. 
• Knowledge of primary containers and drug delivery. 
• Understanding of mold, fixture design and build as well as application of validation processes (IQ/OQ/PQ). 
• Interface with the medical device vendor and tooling company. 
• Knowledge of the regulatory and compliance requirements of device design controls and combination products (i.e. FDA QSR 21 CFR Part 4 and 820/ISO13485 quality system requirements). 
• The duties of this role are conducted in a lab environment.  As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15-30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.  

Job Description:  Quality Assurance TechnicianThis position will serve the role of Engineer I for device development of the client's products including continuous product improvement within the Development function for our client.  The candidate will support technical design and development activities for device and combination products and assist the technology transfer.  Responsibilities:  Quality Assurance Technician

• Manage medical device test method and specification development, including test method development, validation, transfer, and life cycle management.
• Support the laboratory operation such as sample inventory, equipment qualification and maintenance.
• Conduct characterization for device function, assembly, manufacturability, etc. using both CAE and traditional engineering techniques.  
• Test mechanical or electromechanical systems on bench top models or production representative units, during design development and verification. 
• Consult with third parties such as specialist manufacturers and toolmakers. 
• Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.  
• Comply with the Company’s quality assurance requirements as well as applicable regulatory requirements. 

Preferred Qualifications:  Quality Assurance Technician

• Bachelor’s degree in engineering (Biomedical, Chemical, Mechanical, or Electrical Engineering) plus 1-to-3-year experience in laboratory.  Experience with injector-based combination product preferred. 

Physical and Mental Requirements:  Quality Assurance Technician

• [For lab-based positions:] The duties of this role are conducted in a lab environment.  As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

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EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.