Manager of Hardware Quality - #040 at Eko

Eko Agency - Emeryville, CA

Full-time - Manager

Remote - Emeryville, CA

Motor Vehicle and Parts Dealers

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 ultimately to product 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 and evaluation, material qualification, inspection procedure development, supplier corrective action, supplier 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, operating procedures, and task assignments. 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, assist in the preparation of global regulatory submissions, documentation, and technical files, and interface with regulatory bodies during external audits of the quality system as needed. Additionally, the Manager will oversee the company's change management processes and assist technical teams in assessing design changes, including planning, verification, validation, and documentation as required. This position offers a hybrid schedule with a minimum of one office day per week and involves supervising one employee.

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) for new and existing products.
• Implement and maintain an ISO 14971 compliant risk management process.
• Manage Supplier Quality, including evaluation, qualification, and monitoring of suppliers.
• Oversee Supplier Quality Engineering activities, including supplier selection, material qualification, and inspection procedure development.
• 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 as needed.
• 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 and 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.

Benefits

• Paid-time off
• Medical/Dental/Vision, Disability + Life Insurance
• One Medical membership
• Paid Parental Leave
• 401k Matching
• Company sponsored Commuter Benefit Programs
• Employee Assistance Programs
• Remote Work Allowance
• Flexible schedules
• Wellness perks (Wellhub, Carrott, Rightway, OneMedical, Fetch, SmartSpend, SoFi)
• Learning and Development stipend