Quality and Product Engineer

The Quality and Product Engineer will be responsible for ensuring that ClearMask’s products meet applicable regulatory requirements prior to and during commercialization by assisting with the operation and maintenance of the Quality System. This responsibility includes ensuring compliance with all aspects of the Quality System (e.g., document controls, supplier management controls, CAPA, and complaint handling), which includes planning, conducting, and monitoring product quality and the Quality System.

The Quality and Product Engineer works primarily with the Quality and Engineering teams, and will also have the opportunity to assist with product development and manufacturing. The candidate may be located anywhere in the United States, must be eligible to work in the U.S., and will work full-time, 40 hours/week, Eastern Standard Time.

Strong candidates are:

• Highly attuned to detail.
• Well-versed in written communication in English.
• Task-oriented and able to follow-up and close-up tasks in a high pace work environment.
• Able to take initiative and work independently, multitask, and shift workload according to the department/team priorities.
• Highly organized with strong planning and organizational skills with experience managing multiple priorities simultaneously.
• Extremely knowledgeable with Microsoft Office tools (e.g., Word, Excel, PowerPoint) and PDF editor software.

Job duties may include:

• Reviewing new or revised Quality Documents and Quality Records for compliance to established FDA standards to ensure all documentation meets applicable regulatory requirements before processing documents in the Company’s document and record control workflows;
• Working with a multi-disciplinary team, obtaining work-in-progress technical documents (requirements and specifications), and finalizing documentation into formal and controlled design documentation;
• Working with Engineering to develop test plans, create test protocols, conduct testing, finalize test reports, and report test results and conclusions;
• Participating in the issue resolution or design improvement processes;
• Work with the Company’s contract manufacturers on creating, distributing, collecting, or reconciling the product design and production documents and records;
• Planning and conducting data analysis regarding product quality and Quality System processes;
• Assist with manufacturing, product development, and engineering matters as needed; and
• Other duties as required by the Quality and Product Engineering functions of the Company.

Required qualifications:

Candidates must have the following qualifications:

• Bachelor’s degree in Engineering from an accredited university;
• Basic understanding of FDA regulations or ISO 13485 requirements for document management;
• Experience in technical writing or documentation for technical content;
• Self-motivated and willing to learn, attention to detail, ability to take initiative and follow through on projects; and
• Flexibility and adaptability to work in a fast-paced startup environment.

Preferred qualifications:

Candidates are preferred to have the following qualifications:

• At least 2 year of experience working in a medical device or similarly regulated life science company;
• Experience working in quality assurance/control; and
• Experience with and working knowledge of eQMS software tools.

Logistics and Operations Associate

The Operations and Logistics Associate works with ClearMask’s manufacturing and logistics partners to schedule, ship, and monitor orders. They ensure that the customer receives their order in a timely manner and in compliance with the customer’s delivery policies, along with regular shipping updates and other customer service-related correspondence. The role is essential to ClearMask’s order fulfillment process and operations.

The Operations and Logistics Associate reports to the ClearMask CTO and COO and collaborates with the customer service, payments, and finance teams to find solutions for any customer or logistics issues. The candidate may be located anywhere in the United States, must be eligible to work in the U.S., and will work full-time, 40 hours/week, Eastern Standard Time.

Strong candidates are:

• Highly attuned to detail.
• Interested in entrepreneurship.
• Experienced with logistics from prior work and experience.
• Independent and able to take strong initiative.
• Able to adapt quickly to changing circumstances in a fast-paced environment.

Job duties may include:

Order Management

• Answer customer emails related to their order status or logistics quickly and accurately using company-provided templates and text modifications as needed.
• Ensure ClearMask is complying with customer requirements and meeting expectations for order delivery (e.g. meeting timelines, distributor delivery policies, etc.)
• Ensure seamless integration of orders between Shopify and RSL SmartFill system or to shipping schedules to respective manufacturing partners
• Ensure internal shipping policies are implemented based on current production and shipping methods and capabilities
• Work with payments and finance team to pull order delivery information when requested

Supervision of Bulk Orders Delivery throughout Fulfillment Lifecycle

• Assign ship-from locations for bulk orders
• Add shipment information to partner shipment schedule databases
• Create packing slips and commercial invoices as needed
• Ensure shipping and order info is communicated to appropriate manufacturing partners
• Monitor updates in the order statuses by the manufacturer on the corresponding spreadsheets daily
• Review Shopify “BackOrder Report” daily to make sure it is constantly up to date, and ensure all orders are fulfilled promptly
• Transfer order status updates and tracking information notify customers as needed

Management of Shipment Issues Across Logistics and Manufacturing Partners

• Obtain shipping quotes from logistics and domestic carriers
• Raise any issues with third party fulfillment through the appropriate channels, follow-up and ensure any open issues are resolved
• Track and manage freight shipments to warehouses and ensure timely delivery to warehouses using the proper ASNs
• Work with manufacturer and freight forwarder to book freight shipments to warehouses based on demand forecast

We’re always looking for the best talent.