Quality Engineer - Medical Devices - Automationtechies

Are you looking for the next step in your career in Quality Engineering and Management? Our client is looking for a personable and motivated Quality Engineer with experience in industries like medical devices (preferred), CNC machining, aerospace or automotive manufacturing, and 3D printing.

This position is interesting and exciting with its “start-up” culture and a fast paced work environment! In this role you will be managing systems and must have experience with ISO 9000 or 13485.

• Must have a B.S. degree in Engineering and 5+ years of related quality experience, such as in medical devices (preferred), CNC machining, aerospace or automotive manufacturing, and 3D printing.
• Experience implementing and leading all aspects of quality systems for manufacturing. Experience in medical devices, or components sold into medical devices, is a big plus.
• You can brilliantly maintain and continually improve systems including QMS, ERP, change management, CAPA, document control, KPIs/metrics, etc. This is a very hands-on role.
• You can ensure compliance with ISO 13485, including internal auditing and leading our response to external audits. Experience with customer audits and getting onto customers’ Approved Supplier Lists (ASLs) is a plus.
• You are excited to work in the fast-paced environment of a medical device startup, and can “wear multiple hats” when needed, including safety, regulatory, facilities, production scheduling and management, quoting and invoicing, training, inventory management, cost reduction efforts, etc.
• You are well-organized, disciplined, and self-motivated, with the capability to identify and balance multiple priorities.
• You have excellent attention to detail, establish precise written procedures, and ensure they are consistently followed.
• You’re agile and adaptable but work with precision to ensure we deliver top-notch customer experiences, always.
• You have high standards for safety and quality and help instill those in others.
• You confidently maintain excellent rapport with R&D and engineering while ensuring that manufacturing processes stay in control and changes are properly validated and approved.
• You have a passion for excellence and embrace a continuous improvement mindset. You proactively engage consultants, advisors, ongoing education, and other resources to learn new capabilities and take the organization to the next level.
• You have exceptional communication and presentation skills. You communicate successes AND challenges openly. You have the ability to work effectively within a high-caliber team and influence others.

  Key Responsibilities:

• Manage, implement, train, and continually improve Quality Management System (QMS) and compliance with cGMP, ISO 13485 and other applicable standards, including internal and external audits.
• Manage customers’ audits of quality systems and facilitate getting accepted on their ASLs
• Develop and implement manufacturing standard operating procedures (SOPs), policies, procedures, tools, and templates. Manage document control.
• Establish, train, and manage all Safety & Regulatory requirements for equipment, facility, and personnel
• As needed, provide additional expertise and assistance in production operations, safety, customer service, etc.