Director of Quality Assurance - Medical Devices - ONSITE
Location: Lake Forest
Posted on: August 2, 2022
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
Works with Engineering and Manufacturing regarding product and
Initiates and participates in Continuous Improvement projects.
Coordinates the quality aspect of Customer Complaints and CAPA
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
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
15 years of related experience with a minimum of 5 years in a
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
Use of ERP systems to support the quality system and quality
Comfortable working hands-on in a collaborative, mission driven
Excellent conceptual, analytical, and problem-solving ability.
Strong communication skills, both verbal and written
Ability to interface effectively with engineering and manufacturing
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:
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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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