Quality (Inspector) Technician at 4 C Medical Technologies

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Sep, 26

Salary

36.06

Posted On

30 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Inspection, Regulated Environment, Dimensional Inspection, Visual Inspection, Functional Inspection, Nonconformance Management, Root Cause Analysis, Documentation, Calibration, Attention to Detail, Communication Skills, Problem Solving, Continuous Improvement, GD&T, Cleanroom Protocols, Inspection Tools

Industry

Biotechnology

Description

Description WHO WE ARE: If you’re energized by collaboration, driven by purpose, and ready to take ownership of your impact, 4C Medical offers more than just a job—we offer the opportunity to help shape the future of medical innovation. As a growing medical device startup, every team member plays a critical role in advancing technologies that improve patient lives. At 4C Medical, you’ll find an environment where your ideas matter, your growth is prioritized, and your contributions directly influence our success. We’re committed to fostering both personal and professional development in a culture built on accountability, curiosity, and shared purpose. THE OPPORTUNITY The Quality Inspector performs in-process and final device inspection of internally produced components and assemblies for an implantable mitral valve system currently under FDA pivotal clinical trial. This role is central to maintaining the integrity of the company's Quality Management System (QMS) in accordance with 21 CFR Part 820, ISO 13485:2016, and applicable international standards. The Inspector evaluates valve frame subassemblies, sewn textile and biological tissue components, and the associated catheter-based delivery system, ensuring each unit meets established acceptance criteria before advancing through the manufacturing process or releasing. HOW YOU WILL CONTIRBUTE In-Process and Final Inspection Perform dimensional, visual, and functional inspection of nitinol or metal valve frames, sewn tissue leaflets, fabric cuffs, and suture assemblies using calibrated measurement equipment, optical comparators, and microscopy as required. Execute final device inspection and release activities for finished valve assemblies destined for clinical trial use. Inspect catheter-based delivery system subassemblies, including handle mechanisms, shaft components, and deployment interfaces, at defined in-process checkpoints. Complete inspection records, DHR signoffs, and nonconformance reports (NCRs). Nonconformance Management Identify, segregate, tag, and document nonconforming products in accordance with established nonconforming material procedures; initiate NCR workflow and provide objective evidence to support disposition decisions. Participate in root cause investigations and support corrective and preventive action (CAPA) activities as a technical contributor, providing inspection data and trend analysis as requested. Documentation and Records Maintain accurate, complete and legible inspection records in accordance with GDP (Good Documentation Practice). Author and revise inspection work instructions, acceptance criteria documentation, and inspection plans in collaboration with Manufacturing Engineering and Quality Engineering. Equipment and Calibration Identify out-of-tolerance instruments and initiate calibration requests in compliance with the calibration program. Ensure all measurement tools used for regulated inspection activities are within calibration status prior to use. Requirements WHY JOIN US We recognize that meaningful work is supported by meaningful benefits. That’s why we offer a competitive compensation package along with comprehensive benefits designed to support you and your family’s health, well-being, and financial future. Our benefits package includes: Medical Dental Vision Flexible Spending Account (FSA) Basic Life 401(k) Retirement Plan Paid Holidays PTO Maternity/Paternity paid leave WHAT YOU NEED TO SUCCEED (Minimum Qualifications) Education GED, High School diploma or equivalent preferred. Certifications (Preferred) ASQ Certified Quality Inspector (CQI) or Certified Quality Technician (CQT). ASQ Certified Quality Auditor (CQA) is a plus. Experience Minimum 3–5 years of quality inspection experience in a regulated medical device manufacturing environment under 21 CFR Part 820 and/or ISO 13485. Demonstrated experience inspecting complex, precision-assembled products; experience with implantable, sterile, or Class III devices strongly preferred. Hands-on experience with sewn, textile, or biological tissue components, or analogous delicate assemblies requiring fine-tolerance visual and dimensional inspection, is a significant advantage. Prior experience in a start-up or early-stage medical device company, or in an environment without fully established inspection infrastructure, preferred given the foundational nature of this role. Technical Knowledge/Skills Working knowledge of 21 CFR Part 820 Quality System Regulation and ISO 13485:2016 requirements as they apply to inspection, nonconformance, and records management. Familiarity with GD&T (Geometric Dimensioning and Tolerancing) principles and engineering drawing interpretation. Understanding of CAPA, NCR, and deviation/concession processes within a regulated QMS. Knowledge of sterile device handling, cleanroom protocols, and contamination control practices preferred. Proficient with calibrated inspection tools including coordinate measuring principles, calipers, micrometers, and stereo microscopy. Ability to author clear, unambiguous inspection work instructions and objective evidence documentation. Strong attention to detail with the discipline to maintain inspection integrity under production schedule pressure. Effective written and verbal communication skills sufficient to document nonconformances, interface with manufacturing personnel, and present inspection data to quality management. Demonstrated ability to work independently, prioritize competing inspection holds, and escalate appropriately when decisions exceed defined authority. Proficiency with electronic QMS (eQMS) platforms and Microsoft Office; experience with MasterControl, Greenlight Guru, or equivalent preferred. Ability to work in a regulated cleanroom or controlled environment as required by device manufacturing protocols. Strong problem solving and continuous improvement skills It is 4C Medical’s policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state or local laws.

Responsibilities

The Quality Inspector performs in-process and final device inspection of components and assemblies for an implantable mitral valve system. This role is essential for maintaining the integrity of the company's Quality Management System in compliance with regulatory standards.