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.
Email me to apply for this position