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Director of Quality Assurance - Medical Devices - ONSITE

Company: CyberCoders
Location: Lake Forest
Posted on: August 2, 2022

Job Description:

As the Director of Quality Assurance, you will be responsible for leading the corporate product quality system, including setting of corporate quality objectives, managing and improving all aspects of the quality system, product quality, and documentation requirements for medical devices development.

What You Will Be Doing

Define, develop, and implement quality system procedures, work instructions, and forms.

Initiates and performs internal and supplier audits

Works in collaboration with R&D Engineers and executes the quality tasks of the NPD (New product Development) process like Verification/Validation of new products, Risk Management, and Quality Control.

Works with Engineering and Manufacturing regarding product and process improvements

Initiates and participates in Continuous Improvement projects.

Coordinates the quality aspect of Customer Complaints and CAPA processes.

Proficient in clearly communicating directions and in influencing people in adopting the best solutions, tools, working practices and promotes cooperation in defining an excellent technical product.

Must work with limited supervision and will be involved in and have input to project planning.

What You Need for this Position

BS in Mechanical Engineering, Electrical Engineering, or related field REQUIRED

15 years of related experience with a minimum of 5 years in a managing role.

Medical device manufacturing environment is a must.

REQUIRED Strong Working Experience With ISO 13485.

Expertise with investigational tools such as Fishbone diagram, Brainstorming, and Pareto charts is a must.

Quality Manager and Quality Auditor certifications (CQM, CQA) are a plus.

Use of ERP systems to support the quality system and quality initiatives.

Comfortable working hands-on in a collaborative, mission driven environment

Excellent conceptual, analytical, and problem-solving ability.

Strong communication skills, both verbal and written

Ability to interface effectively with engineering and manufacturing personnel.

Proven Competencies In

  • Analysis and reporting
  • Communication and presentation
  • Customer focus
  • Change champion
  • MS Office suite (Word, Excel, PowerPoint)
    For your hard work and dedication, earn a generous salary plus 10% bonus with stock option, competitive benefits package including 401, plus more. This client Mandates working in a Covid Vaccinated facility. So, if you are a Director of Quality Assurance with experience, please apply today!

    Email Your Resume In Word To

    Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also:
    • Please do NOT change the email subject line in any way. You must keep the JobID: linkedin : NG-1673787 -- in the email subject line for your application to be considered.***
      Nyna Goldberg - Principal Recruiter - CyberCoders

      Applicants must be authorized to work in the U.S.

      CyberCoders, Inc is proud to be an Equal Opportunity Employer

      All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

      Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Keywords: CyberCoders, Lake Forest , Director of Quality Assurance - Medical Devices - ONSITE, Executive , Lake Forest, California

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