Quality Technician

Quality Technician

The Quality Technician performs in-process and final inspection of internally produced components and assemblies for an implantable mitral valve system that is currently in an FDA pivotal clinical trial. This role plays a critical part in maintaining the integrity of the Quality Management System (QMS) in accordance with 21 CFR Part 820, ISO 13485:2016, and applicable international standards. The Quality Technician evaluates valve frame subassemblies, sewn textile and biological tissue components, and the associated catheter-based delivery system to ensure each unit meets established acceptance criteria before progressing through manufacturing or being released for clinical use.

Responsibilities

• 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 intended for clinical trial use, ensuring all acceptance criteria are met.
• Inspect catheter-based delivery system subassemblies, including handle mechanisms, shaft components, and deployment interfaces, at defined in-process checkpoints to verify conformance.
• Complete inspection records, device history record (DHR) signoffs, and nonconformance reports (NCRs) accurately and on time.
• Identify, segregate, tag, and document nonconforming products in accordance with established nonconforming material procedures, initiating NCR workflows and providing objective evidence to support disposition decisions.
• Participate as a technical contributor in root cause investigations and support corrective and preventive action (CAPA) activities by providing inspection data and trend analysis.
• Create and maintain accurate, complete, and legible inspection records in accordance with Good Documentation Practice (GDP).
• Author and revise inspection work instructions, acceptance criteria documentation, and inspection plans in collaboration with Manufacturing Engineering and Quality Engineering.
• Identify out-of-tolerance instruments and initiate calibration requests in compliance with the calibration program.
• Verify that all measurement tools used for regulated inspection activities are within calibration status prior to use.
• Handle sterile and delicate components in alignment with cleanroom protocols and contamination control practices when required.
• Work independently to prioritize competing inspection holds and escalate issues appropriately when decisions exceed defined authority.
• Collaborate effectively with manufacturing personnel and quality management to communicate inspection results, nonconformances, and quality trends.
• Contribute to continuous improvement initiatives by applying strong problem-solving skills to enhance inspection processes and product quality.

Essential Skills

• Minimum 3–5 years of quality technician experience in a regulated medical device manufacturing environment operating under 21 CFR Part 820 and/or ISO 13485.
• Demonstrated experience inspecting complex, precision-assembled products, with experience in implantable, sterile, or Class III devices strongly preferred.
• Hands-on experience inspecting sewn, textile, or biological tissue components or similar delicate assemblies requiring fine-tolerance visual and dimensional inspection.
• Working knowledge of 21 CFR Part 820 Quality System Regulation and ISO 13485:2016 requirements as they apply to inspection, nonconformance management, and records control.
• Familiarity with GD&T (Geometric Dimensioning and Tolerancing) principles and strong ability to interpret engineering drawings.
• Understanding of CAPA, NCR, and deviation or concession processes within a regulated QMS.
• Proficiency with calibrated inspection tools, including calipers, micrometers, and stereo microscopy, as well as an understanding of coordinate measuring principles.
• Proven ability to maintain strict attention to detail and uphold inspection integrity under production schedule pressure.
• Effective written and verbal communication skills to document nonconformances, interface with manufacturing personnel, and present inspection data to quality management.
• Demonstrated ability to work independently, manage priorities, and escalate issues when necessary within defined authority limits.
• Proficiency with electronic QMS (eQMS) platforms and Microsoft Office applications.
• Ability to work in a regulated cleanroom or controlled environment as required by device manufacturing protocols.
• Strong problem-solving abilities and a continuous improvement mindset.

Additional Skills & Qualifications

• GED, high school diploma, or equivalent education preferred.
• ASQ Certified Quality Inspector (CQI) or Certified Quality Technician (CQT) certification preferred.
• ASQ Certified Quality Auditor (CQA) certification is a plus.
• Knowledge of sterile device handling, cleanroom protocols, and contamination control practices.
• Prior experience in a start-up or early-stage medical device company, or in an environment without fully established inspection infrastructure, is highly valued.
• Experience with implantable, sterile, or Class III medical devices is strongly preferred.
• Experience with eQMS platforms such as MasterControl, Greenlight Guru, or equivalent systems.
• Experience in medical device design assurance, design control, risk management, and validation is beneficial.
• Experience performing visual inspection, quality checks, and calibration activities using tools such as micrometers and calipers.
• Ability to author clear, unambiguous inspection work instructions and provide objective evidence in support of quality decisions.

Work Environment

This role is based on-site in Maple Grove, MN, within a regulated medical device manufacturing environment. The Quality Technician works closely with manufacturing and quality teams in cleanroom or controlled areas, following sterile handling procedures, contamination control practices, and established device manufacturing protocols. The position supports a growing organization focused on an innovative, life-changing implantable mitral valve system, offering the opportunity to contribute to an FDA pivotal clinical trial product. The culture emphasizes internal growth, career development, and a people-first mindset, with a strong focus on collaboration, accountability, and promoting from within.

Job Type & Location

This is a Permanent position based out of Maple Grove, MN.

Pay and Benefits

The pay range for this position is $62000.00 - $75000.00/yr. Medical Dental Vision Flexible Spending Account (FSA) Basic Life 401(k) Retirement Plan Paid Holidays PTO Maternity/Paternity paid leave

Workplace Type

This is a fully onsite position in Maple Grove, MN.

Application Deadline

This position is anticipated to close on Jul 31, 2026.