Quality Technician

Overview Job Title: 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 sub‑assemblies, 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 sub‑assemblies, 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 escape 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 escape 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. Background 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. Job Type & Location This is a Permanent position based out of Maple Grove, MN. Pay & Benefits Pay range: $62,000.00 – $75,000.00/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. Equal Employment Opportunity The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI) We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr Actalent