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Quality Engineer - Manufacture Focus

Company Name: Midmark
Location: Torrance, CA
Job Type: Full-Time
Contact Name: Sandra Dancy
Phone: 
Fax: 
Email: To Apply visit: http://midmark.referrals.selectminds.com/jobs/quality-engineer-376
Salary: 82,000 - 92,000

Job Description

Summary - Quality Engineer (Manufacturing Focus) 

Provide quality & manufacturing engineering support and conduct activities to improve and assure quality design and manufacturing of medical devices and components.  Is responsible to lead, organize and improve Midmark owned tooling, process capability, cost and quality to achieve both corporate and operational standards.
  
Responsibilities - Prepare FDA submissions for new products and product changes as required to ensure timely approval for market release and in accordance with applicable regulations, standards and guidance.

  • Lead and provide guidance to work teams comprised of senior engineering and marketing personnel with regard to regulatory planning and execution.
  • Review and analyze product complaints for appropriate domestic and international filings as part of product post-market surveillance.
  • Conduct post-market surveillance such as literature reviews, clinical study reviews, etc.
  • Assist with product hazard analyses and recall assessments.  Advise technical, marketing and sales teammates on regulatory requirements (e.g., Design Controls, UDI, Labeling, and Promotion).
  • Provide guidance and review of product labeling, promotional material, change control and other related product documentation.
  • Maintain regulatory affairs product files to support compliance with requirements and standards.
  • Maintain the company’s Medical Device Listing and Device Establishment registration forms.

Job Requirements

This position assures company compliance to all pertinent United States FDA, state, and international regulatory requirements which are applicable to the design, manufacture and distribution of medical and diagnostic devices.

  • Knowledge of international quality and product standards for electro-mechanical equipment (e.g. ISO14971, ISO13485, EN60601, IEC62304, etc.)
  • Excellent written and oral communication
  • Strong project management and organizational skills.
  • Excellent verbal and written communication skills.
  • Strong analytical and problem solving skills.
  • Good leadership, analytical, written and interpersonal skills 

  Education/Experience - Quality Engineer (Manufacturing Focus)  

  • BA/BS degree in engineering or life sciences
  • At least five years of progressive experience in domestic/international regulatory submissions, design control systems and/or regulatory compliance.
  • Experience with product registration requirements US, Canada, EU and other major international markets i.e. China, Australia, Brazil, Saudi Arabia, etc.
  • Experience in the preparation of 510(k) submissions
  • Experience with development and post market support of Class I and II Medical Devices

 

To Apply visit:   http://midmark.referrals.selectminds.com/jobs/quality-engineer-376