Job Openings

Quality Control / New Product Development Coordinator

Waco, TX

Posted: 11/20/2020 Employment Type: Direct Hire Function: Engineering, HSE/Quality Assurance Job Number: 20195 Pay Rate: $80,000-$85,000

Job Description

Quality Control / New Product Development Coordinator

Position Type: Direct Hire

Position Location: Waco, TX

Position Salary: $80,000 – $85,000 (Depending on Experience)

Responsibilities:

  • Primary responsibility for record-keeping and document management for the company regulated businesses, including Medical Device, Pharmaceutical, Life Sciences and Microelectronics. 
  • Interface with all levels of sales and operations, both domestically and internationally, and will follow-up on and report on project status. 
  • Maintain files of Finished product specifications, coordinate approvals with sales and customers
  • Organize distribution and process procedures to maintain compliance to ISO 90001, ISO 13485, and cGMP
  • Provide Certificates of Compliance for custom products, and technical documents such as technical data sheets as requested by Sales Team and customers
  • Submit cost and sample requests to counterparts internationally, and follow up on project status
  • Lead a weekly status meeting with NPD team and publish notes. 
  • Follow up on actions required from NPD and sales.
  • Maintain samples and reports of all new product development
  • Interact with regulatory agencies such as US FDA for certification, approvals/certificates, and document from those agencies.
  • Review and report that the company is within compliance to ship and store hazardous materials.
  • Maintain MRB (Material Review Board) area and actively work to correct product issues and release products.
  • Identify and resolve discrepancies in documentation and labeling.
  • Create and control new documentation as needed.
  • Prepare internal documentation for submittal to inspectors and auditors from regulatory agencies, customers, and certifying agency auditors.
  • Other projects as assigned involving QC and New Product Development

Requirements:

  • Bachelor’s degree in a science related background, will consider other related degrees
  • 5+ years working experience in regulatory and/or product development/product manufacturing working with FDA and ISO regulations
  • Prior experience with documentation and project management within a life science company that maintains an ISO13585, cGMP quality system
  • Working knowledge of US FDA medical device for manufacturing (cGMP & FDA 21 CFR 820) and packaging.
  • Familiarity with ISO 13485 and ISO 9001.
  • High level of organization skills required
  • Strong Ability to work independently in a fast paced, high pressure environment is required
  • Advanced knowledge of Microsoft Excel, Word and Outlook
  • Advanced communication and problem-solving skills are required for the role

Benefits:

  • Full Benefits (Medical, Dental, Vision)
  • 401K + Matching
  • Relocation Assistance

Due to the high volume of applications we typically receive, we regret that we are not able to personally respond to all applications. However, if you are invited to take the next step in the process, you will typically be contacted within 3 weeks of submitting your application

Meet Your Recruiter

Daniel Heidrick
Recruiter - Murray Technical

Specializing in placing talent in Engineering, Manufacturing, and Operations roles.
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