Quality Engineer

Threadstone; Severna Park (MD); Sur place; USD 70 000 - 90 000; Plein temps

Résumé du poste

Threadstone in Severna Park, MD, is seeking a full-time Quality Engineer to develop, implement, and maintain quality systems that meet FDA and ISO 13485. You will collaborate with manufacturing, engineering, and regulatory teams to resolve quality issues and improve product reliability.

Responsibilities include conducting inspections, product and process validations, managing nonconformance investigations, supporting CAPA, and updating SOPs and quality records.

Qualifications

• Experience building and improving quality systems and processes.
• Experience with in-process and final inspections and data reviews.
• Familiarity with FDA and ISO 13485 standards in medical device manufacturing.
• Ability to perform risk-based decision-making and CAPA tracking.

Responsabilités

• Develop, implement, and maintain quality systems supporting FDA and ISO 13485.
• Conduct inspections, validations, and data reviews for product quality.
• Lead CAPA investigations and corrective actions.
• Support internal and external audits and maintain quality records.

Connaissances

Quality Engineering

Quality Management

Root Cause Analysis

CAPA Management

FDA & ISO 13485 knowledge

Documentation & Audit support

Formation

Bachelor’s degree in engineering or related technical field

Description du poste

Company Description

Threadstone is a specialized manufacturer of UHMWPE sutures and suture tapes, serving customers with customized products designed to meet specific technical and clinical requirements. The company holds FDA clearance for its Hypersuture and HyperTape product lines and can provide non-sterile, sterilized, and white/private label sterilized products. Threadstone operates as an FDA-registered and ISO 13485 certified manufacturer, reflecting a strong commitment to quality and regulatory compliance. The organization partners closely with medical device customers, offering flexible manufacturing capabilities and responsive support for questions and new inquiries.

Role Description

This full-time, on-site Quality Engineer role is based in Severna Park, MD. The Quality Engineer will develop, implement, and maintain quality systems and procedures that support FDA and ISO 13485 requirements for sutures and suture tapes. Typical responsibilities include conducting inspections, overseeing product and process validations, managing nonconformance investigations, and supporting corrective and preventive actions (CAPA). The role also involves collaborating with manufacturing, engineering, and regulatory teams to resolve quality issues, improve product reliability, and update documentation such as SOPs, work instructions, and quality records. The Quality Engineer will monitor quality metrics, participate in internal and external audits, and contribute to continuous improvement initiatives across the organization.

Qualifications

• Demonstrated skills in Quality Engineering and Quality Management, including developing, implementing, and improving quality systems and processes.
• Experience with Quality Control activities such as in-process and final inspections, testing, and data review to ensure Product Quality.
• Background in Quality Assurance, including documentation control, audit support, and compliance with FDA and ISO 13485 standards.
• Ability to evaluate and maintain Product Quality through root cause analysis, CAPA management, and risk-based decision-making.
• Bachelor’s degree in engineering, quality, or a related technical field, or equivalent practical experience in a regulated manufacturing environment.
• Familiarity with medical device or healthcare product regulations and quality requirements (FDA, ISO 13485) is strongly preferred.
• Strong analytical, problem-solving, and organizational skills, with attention to detail and accuracy in documentation.
• Effective communication and collaboration skills, with the ability to work cross-functionally and support shop-floor personnel and leadership.