Quality Manager

Willow Laboratories; Irvine (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

Join a forward-thinking company dedicated to developing innovative medical technologies that save lives. As a Quality Manager, you will play a pivotal role in leading quality systems and ensuring product excellence in a dynamic environment. Your expertise in quality management, ISO standards, and analytical skills will help shape the future of advanced electronic medical devices. Collaborate with cross-functional teams to drive continuous improvement and uphold the highest quality standards. This is an exciting opportunity to make a significant impact in the wellness and fitness industry while working in a supportive office environment in Irvine, CA.

Qualifications

• 5+ years of experience as a Quality Engineer in medical device manufacturing.
• Proficient in investigation tools like Fishbone diagrams and Pareto charts.

Responsibilities

• Define and implement quality system procedures and work instructions.
• Collaborate with R&D Engineers on NPD processes and quality control.

Skills

Analytical Skills

Problem-Solving Skills

Communication Skills

Quality Management

Data Analysis

Change Management

Education

BSc in Mechanical Engineering

BSc in Electrical Engineering

Tools

Minitab

ISO 13485

MS Office Suite

Job description

This position plays a crucial role in our organization, focusing on the development of medical technology and innovative, world-class products that save lives. The Quality Manager will lead the corporate product quality systems, including setting quality goals, managing and improving the quality system, product quality, and documentation for advanced electronic medical devices.

Duties & Responsibilities:

1. Define, develop, and implement quality system procedures, work instructions, and forms.
2. Work with limited supervision and contribute to project planning.
3. Communicate clearly and influence teams to adopt best solutions and practices, fostering cooperation for excellent technical products.
4. Initiate and perform internal and supplier audits.
5. Collaborate with R&D Engineers on NPD processes, including Verification and Validation, Risk Management, and Quality Control.
6. Coordinate with Engineering and Manufacturing on product and process improvements.
7. Participate in Continuous Improvement projects.
8. Manage the quality aspects of Customer Complaints and CAPA processes.

Minimum Qualifications and Experience:

• BSc in Mechanical or Electrical Engineering with at least 5 years of experience as a Quality Engineer in a medical device manufacturing environment.
• Strong conceptual, analytical, and problem-solving skills.
• Excellent verbal and written communication skills, with the ability to interface effectively with engineering and manufacturing teams.
• Experience with ISO 13485 is mandatory.
• Proficient in investigation tools such as Fishbone diagrams, Brainstorming, and Pareto charts.
• Certifications like CQE or CQA are advantageous.
• Experience with data analysis software like Minitab is a plus.
• Familiarity with ERP systems supporting quality initiatives.
• Skills in analysis, reporting, communication, presentation, and change management.
• Proficiency in MS Office Suite.

Preferred Qualifications:

• Experience in both large structured and small entrepreneurial organizations.

Physical Requirements & Work Environment:

Located in Irvine, CA, primarily in an office setting. Requires sitting, standing, walking, and daily computer use. Some travel and ability to operate a vehicle are necessary. Reasonable accommodations can be provided for individuals with disabilities.

Seniority Level

• Mid-Senior level

Employment Type

• Full-time

Job Function

• Quality Assurance

Industries

• Wellness and Fitness Services