Title: Director of Quality Assurance - Onsite Daily
Location: Onsite in Lake Forest, CA
Compensation: $160-210K + Bonus + Stock Option
Must Have: Degree in Mechanical, Electrical or related field, and ISO 13485
As the Director of Quality Assurance you will lead the corporate product quality system which includes setting 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
Collaborate with R&D Engineers, execute the quality tasks of the New product Development like verification/validation, 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.
Must work with limited supervision and will be involved in and have input to project planning.
Top Reasons to Work with Us
Generous Salary with Bonus
Stock options
Medical (HMO or PPO), dental and vision
Flexible spending plan for dependent care and medical
401k
Vacation (starting at 3 weeks)
Sick time
Short- and long-term disability
Lunch on Mondays
Breakfast for early birds
What You Need for this Position
Bachelors Science Degree in Mechanical Engineering, Electrical Engineering, or related field REQUIRED
15 years of related experience
At least 5 years success in a managing role
Must have Medical Device manufacturing environment
Must have strong ISO 13485 experience
Must have expertise with investigational tools - Fishbone diagram, Brainstorming, and Pareto charts or similiar
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
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!
Applicants must be authorized to work in the U.S.
Email me to apply for this position