Job Summary:
This position will be an integral part of our organization that is responsible for the development of medical technology and innovative, world-class products that save people’s lives. The Quality Manager is responsible for leading the corporate product quality systems, including setting corporate quality goals, managing and improving all aspects of the quality system, product quality, and documentation requirements for advanced electronic medical devices.
Duties & Responsibilities:
- Defines, develops, and implements quality system procedures, work instructions, and forms.
- Must work with limited supervision and will be involved in and have input to project planning.
- 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.
- 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, such as Verification and 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.
Minimum Qualifications and Experience:
- BS in Mechanical or Electrical Engineering with minimum of 5 years of working experience, as a Quality Engineer, in a medical device manufacturing environment is a must.
- Excellent conceptual, analytical, and problem-solving ability.
- Good communication skills, both verbal and written, and the ability to interface effectively with engineering and manufacturing personnel.
- Working experience with ISO 13486 is a must.
- Working experience with investigation tools such as Fishbone diagram, Brainstorming, and Pareto charts is a must.
- Quality Engineer and Quality Auditor certifications (CQE, CQA) are a plus.
- Working experience with Minitab or any other data analysis software is a big plus.
- Use of ERP systems to support the quality system and quality initiatives.
- Proven competencies in:
- Analysis and reporting
- Communication and presentation
- Customer focus
- Change champion
- MS Office suite (Office, Word, Excel, PowerPoint)
Preferred Qualifications:
- Experience working in both large structured and small entrepreneurial organizations.
Physical requirements/Work Environment:
This position is located in Irvine, CA.
This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary so the ability to operate a motor vehicle and maintain a valid driver’s license is required.
The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.
