#040 - Manager of Hardware Quality

$211,000 - $216,000/Yr

Unclassified - Emeryville, CA

Full-time - Manager

Remote - Emeryville, CA

About the position

Eko Health, Inc seeks a Manager of Hardware Quality at its facility located at 2100 Powell St, Suite 300, Emeryville, CA 94608. This role is pivotal in the implementation and improvement of Eko's Design Assurance program for Hardware products. The Manager will oversee Design Assurance activities related to the development of both new products and product improvements, guiding projects from initial concept through product development, verification planning, testing, and implementation. The position requires the authoring, editing, organizing, maintaining, and reviewing of Design History Files (DHF) for both new and existing products, ensuring compliance with industry standards and regulations. In addition, the Manager will be responsible for the implementation and maintenance of an ISO 14971 compliant risk management process. This includes managing Supplier Quality, which encompasses evaluation, qualification, and monitoring of suppliers. The Manager will oversee all activities related to Supplier Quality Engineering, including supplier selection, material qualification, inspection procedure development, corrective actions, assessments, performance reviews, and supplier development. The role also involves ensuring compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, and operating procedures. The Manager will maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. They will audit, identify, and support the implementation of design process improvements and assist in the preparation of global regulatory submissions and documentation. The Manager will interface with regulatory bodies during external audits of the quality system as needed and oversee the company's change management processes. Additionally, they will assist technical teams in assessing design changes, including planning, verification, validation, and documentation as required. This position offers a hybrid schedule, requiring a minimum of one office day per week.

Responsibilities

• Implement and improve Eko's Design Assurance program for Hardware products.
• Oversee Design Assurance activities for new product development and product improvements.
• Author, edit, organize, maintain, and review Design History Files (DHF).
• Implement and maintain an ISO 14971 compliant risk management process.
• Manage Supplier Quality, including evaluation, qualification, and monitoring.
• Oversee Supplier Quality Engineering activities, including supplier selection and evaluation.
• Ensure compliance with FDA regulations and other regulatory requirements.
• Maintain positive communication and collaboration with employees, customers, contractors, and vendors.
• Audit and support implementation of design process improvements.
• Assist in preparation of global regulatory submissions and documentation.
• Interface with regulatory bodies during external audits of the quality system.
• Oversee change management processes and assist in assessment of design changes.

Requirements

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, Manufacturing, Quality Assurance or a related field plus 5 years of experience as a Quality Assurance Engineer or related occupation.
• Alternatively, a Master's degree in the same fields plus 3 years of experience as a Quality Assurance Engineer or related occupation.
• Experience with implementation of medical device design control and risk management methodologies compliant to ISO14971:2019.
• Experience supporting a medical device Research and Development team as a Quality Assurance member.
• Knowledge of medical device design standards such as IEC 60601-1, ISO 62366-1.
• Familiarity with Medical Device Quality Management System requirements pursuant to international regulations, such as US FDA 21CFR820, EU-MDD/MDR, ISO13485:2016.
• Experience managing medical devices throughout their product lifecycles.

Nice-to-haves

• Experience with cross-functional teams in a medical device environment.
• Familiarity with FDA regulatory submissions and documentation processes.

Benefits

• 401(k) matching
• Dental insurance
• Disability insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Volunteer time off
• One Medical membership
• Parental Leave
• Work from home equipment stipend
• Wellness programs
• Learning and Development stipend