Manufacturing Quality Technician

About Mendaera, Inc.

Mendaera is developing technology that will enable all healthcare providers to do more for their patients. Our platform combines real-time imaging, robotics, and artificial intelligence to make precise and consistent intervention more accessible. Our aim is to eliminate barriers in the patient journey, accelerate recovery, delight customers, and reduce cost of care.

About the Opportunity

We are seeking an experienced Quality Specialist to lead Quality System operations for medical device products. This role will report to the Sr. Manager, Regulatory Affairs and Quality Assurance and will not have any direct reports.

Salary range: $95,000 to $115,000 (this is an hourly position)

About You

We are looking for candidates who: thrive in fast-paced environments; can create frameworks and work-products from scratch; are able to level between micro and macro analysis; possess critical and system thinking ability; are detail oriented.

Responsibilities include:

Document Control

• Process documentation changes: manage the initial release of QS documents and revision of existing documents, managing the DCO reviews, and releasing documents within an electronic Quality Management System (eQMS).
• Promptly respond to questions and issues raised by Originators and Approvers.
• Review records and documents, for completeness and compliance with QSR and ISO requirements.
• Ensure the eQMS (NCMR, CAPA, Quality Processes, and etc.) operates effectively and efficiently to meet the needs of internal customers, business objectives, and corporate quality objectives.
• Support the maintenance of the filing systems for all Quality System documents to ensure easy retrieval of documents when needed

Operations Quality Support

• Support incoming inspection activities by reviewing and verifying documentation, specifications, and test results for raw materials, components, and finished goods.
• Perform visual and dimensional inspections using appropriate tools and techniques to ensure product conformance to specifications.
• Identify, document, and escalate nonconformances observed during inspection or operations support.
• Conduct first-line investigations of nonconformances or quality events, including initial root cause assessment and documentation of findings.
• Maintain accurate records of inspections, nonconformance reports (NCRs), and investigation activities within the eQMS.

General Responsibilities

• Drive continuous improvement by offering constructive feedback on existing processes
• Adhere strictly to Good Documentation Practices and Good Manufacturing Processes
• Ensure compliance with all corporate, regulatory, safety, and production policies and procedures
• Exhibit strong organizational skills and an attention to detail
• Work independently as necessary to support quality objectives

 

Desired Skills and Experience

• Minimum AA degree in a related field or equivalent level of experience
• 3+ years of medical device complaint handling process
• Familiarity with CRM & eQMS system such as SalesForce, Arena, or equivalent
• Familiarity and understanding in a regulated environment (ISO 13485 & FDA)
• Working knowledge using common inspection tools, including operation of automated visual inspection systems.
• Working statistical knowledge for trend analysis
• Experience working with MS Office and Excel or Google Docs and Sheets
• Excellent technical verbal/written communication skills
• Process orientation when planning and performing work