Quality Systems Manager- Medical Device

We are a global, high-volume, and service-driven supply chain management company. Our award-winning leadership develops and implements highly optimized product delivery strategies for our customers, representing leading brands in the automotive, energy, technology, and medical industries. We are an exciting company committed to equal opportunities for all people. Every minute of every day our staff and systems positively impact manufacturing, e-commerce, fulfillment, and logistics operations all over the world.

We are a destination for passionate, talented, and service-oriented professionals. We continuously invest in our employees, reward bold thinking, promote teamwork, and focus on community engagement. Our inclusive culture is built on diversity, acceptance, respect, and operational excellence. See your career grow in an environment where fresh ideas and professional development are encouraged. Sound exciting?

Are you a quality-focused professional who excels in leading a team in a high-volume manufacturing environment? Are you looking to be an integral part of a top-performing division within a technology-driven growing organization that continuously invests in the training and development of its employees?

Be part of a world-class team that continues to grow fast. Expand your career in a real-world professional environment where your ideas and contributions will shape the stature and recognition of our corporate brand globally.

looking for a Quality Manager who is:

• Results-driven, juggling multiple priorities and able to succeed in a multi-client, fast-paced environment
• Well-versed in ISO 9000, ISO 13485 and the development of quality plans, and a variety of continuous improvement tools
• Able to successfully work in a collaborative manner and influence needed change
• Experienced with proven results to implement change
• Deploying a team-oriented approach to creating a cohesive Quality work environment

Here's what you need to succeed in the role:

• At least five years and preferably longer experience in QA systems implementation and management
• Understanding ISO requirements for Quality Systems
• Experience in developing, implementing, administrating, and leading ISO 13485 system is preferred
• Quality Engineer experience preferred
• Bachelor’s degree in a related field or equivalent technical degree and experience

You will be responsible for:

• In collaboration with the rest of the Quality Team, leading the Standard for Excellence throughout ALOM’s organization
• Initiating, implementing, and maintaining quality improvement activities to ISO standards and as appropriate (e.g., Kaizen, Six Sigma) to raise performance
• Maintaining Fremont system & facility compliance with FDA cGMP requirements
• Educating and training direct reports as well as all employees as to their impact on the quality management system
• Managing and improving the Quality Management System
• Serving as the primary quality control resource for problem identification, resolution, loss reporting, and continuous improvement
• Driving the continuous improvement process, using tools such as corrective and preventive action, data collection and analysis, and preparation and execution of quality meetings
• Preparing quality plans and reports for customers and participating in customers vendor audits as well as customer satisfaction surveys
• Participating in managing supplier relations, including supplier qualification and supplier performance evaluation
• Supervising quality inspectors and supporting quality inspection, defining tasks and scope of work functions
• Performing root-cause analysis and other problem-solving activities to identify effective corrective actions and process improvements
• Compliance management to environmental requirements (ISO 14001) may eventually be added to the responsibilities.