QA Lab Technician

Location: Emerson

Job Title:

Quality Assurance Technician

Job Description

This role focuses on inspecting, measuring, and documenting the quality of instruments and medical devices to ensure they meet strict customer, regulatory, and internal specifications. The Quality Assurance Inspector plays a key part in supporting patient safety by maintaining high quality standards, updating quality systems, and collaborating with teams to resolve non-conformances and quality concerns.

Responsibilities

+ Inspect incoming instruments and components using micrometers, calipers, and other measurement tools to verify they meet required specifications.

+ Review engineering drawings and physical instruments to confirm that products match documented requirements and customer expectations.

+ Evaluate customer drawings for custom OEM orders and ensure all products conform to specified dimensions, tolerances, and quality standards.

+ Report on the condition of parts, identifying and documenting non-conformances and any items that are out of specification (OOS).

+ Record inspection outcomes in quality systems, complete all necessary documentation, and promptly flag non-conforming items for further action.

+ Update the Quality Management System (QMS) and paper-based documents as needed to support audits and maintain accurate quality records.

+ Apply product identification markings using laser or chemical etching methods, and clean and neutralize items as required to ensure safe handling.

+ Handle product returns and customer complaints by assessing quality concerns, documenting findings, and coordinating repairs or rework as appropriate.

+ Support regulatory compliance activities by preparing documentation, maintaining relevant databases, and following applicable regulations and internal procedures.

+ Utilize Good Manufacturing Practices (GMP) in daily work to maintain consistent, high-quality production and inspection standards.

+ Follow all applicable quality and safety standards, including industry-specific regulations and internal quality procedures.

+ Maintain cleanliness and organization in the quality control area to support safe, efficient, and compliant operations.

+ Monitor inventory of quality-related supplies, such as gauges and consumables, and request replenishment when levels are low.

+ Collaborate with quality assurance and operations team members to resolve quality issues and continuously improve inspection processes.

Essential Skills

+ Quality assurance and inspection experience, preferably in a medical device environment, with openness to candidates from other regulated industries.

+ Hands-on experience using micrometers and calipers to measure and verify product dimensions.

+ Strong familiarity with Good Manufacturing Practices (GMP) and quality control processes.

+ Ability to read and interpret technical drawings, blueprints, and specifications with a high degree of accuracy.

+ Great attention to detail and accuracy when inspecting parts, reviewing documentation, and recording quality data.

+ Understanding of regulatory and quality frameworks such as ISO 13485, FDA 21 CFR 820, and EU MDR.

+ High school diploma or equivalent education.

+ Ability to document inspection results clearly and completely in both electronic quality systems and paper records.

+ Capability to identify non-conforming items and communicate issues effectively to the appropriate stakeholders.

Additional

Skills & Qualifications

+ Prior quality assurance experience specifically within the medical device sector is preferred.

+ Familiarity with laboratory or controlled environment practices related to inspection and testing.

+ Experience working within a formal Quality Management System (QMS) and supporting internal or external audits.

+ Comfort working with product identification methods such as laser marking and chemical etching.

+ Ability to manage product returns and customer complaints with a focus on root cause analysis and corrective actions.

+ Strong organizational skills to maintain orderly documentation, work spaces, and inventory of quality tools and supplies.

+ Team-oriented mindset with the ability to collaborate closely with quality assurance and operations teams.

+ Interest in contributing to a mission-driven organization focused on helping patients and improving healthcare outcomes.

Work Environment

+ The role is based in a small, close-knit organization with a team-oriented, family-style culture.

+ The quality assurance team consists of approximately five people, working closely with an…