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Director of Quality Assurance - Medical Devices - ONSITE

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Lake Forest, CA
Full-time $160,000.00 - $240,000.00
Posted 01/18/2023
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Director of Quality Assurance needed now to lead the corporate product quality system which includes 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

Bachelors Science Degree in Mechanical Engineering, Electrical Engineering, or related field REQUIRED
15 years of related experience
Minimum of 5 years success in a managing role
Medical device manufacturing environment is Required
REQUIRED Strong working experience with ISO 13485
Expertise with investigational tools - Fishbone diagram, Brainstorming, and Pareto charts is a must
Quality Manager and Quality Auditor Certifications - CQM, CQA are a plus
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)

What's In It for You

Medical (HMO or PPO), dental and vision
Flexible spending plan for dependent care and medical
401k (no matching yet)
Bonus plan
Stock options
Vacation (starting at 3 weeks)
Sick time
Short- and long-term disability
Lunch on Mondays
Breakfast for early birds
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!
Colorado employees will receive paid sick leave. For additional information about available benefits, please contact Nyna Goldberg

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

Additional ways to apply

Preferred Skills

  • Quality Assurance
  • Medical Device
  • Manufacturing
  • Continuous Imp
  • Manager
  • Corporate Quality Objectives
  • New Product Development
  • CAPA Processes
  • CQM
  • CQA

Nyna Goldberg is recruiting for this position and the positions below.
email meEmail me to apply for this position

Mechanical Manufacturing Engineer II
Aliso Viejo, CA   Full-time $74,000.00 - $110,000.00
Senior Human Factors Engineer - Masters or Ph.D.
Newport Beach, CA   Full-time $123,000.00 - $184,000.00
Job ID: NG-1673787

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.

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CyberCoders is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.  CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email Benefits@cybercoders.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis. UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of CyberCoders.

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