Description

This is a senior-level position that is responsible for the quality oversight of design control and risk management activities for medical devices manufactured by NextStep Arthropedix. This individual will work closely with product development teams, suppliers, and testing partners throughout the entire device life cycle. This role oversees the development, implementation, and continuous improvement of device-related quality processes and procedures and ensures compliance with the relevant standards and regulatory requirements for devices. Responsibilities include overseeing and managing Operations, Quality Management System and Quality Inspection, leading the Operations team meetings, managing quarterly goals for Operations and Quality Teams, leading quality review of all technical documentation for design and development, supporting compliance with filing and implementing changes, timely handling of investigations and CAPAs, leading continuous improvement initiatives, managing QA interface with suppliers and testing partners, and supporting audits and inspections as a Subject Matter Expert.

Requirements

A minimum of Associates Degree of Engineering, Business or related technical or scientific discipline. 5+ years of Quality Inspection and QMS experience. 2+ years of working experience in medical devices within a medical device, biotech, or pharmaceutical company. Experience in development technical oversight, and related risk assessment/management. Quality oversight experience of device processes and documentation. Working knowledge and application of device regulations, including 21 CFR 820, 2017/745, ISO 13485, ISO 14971. Experience in supplier management and relations, including quality agreement generation and maintenance. Working knowledge of process development and validation principles. Experience in hazard analysis and application of risk analysis tools such as FMEA, Fishbone, etc. Experience with regulatory inspections and interaction with regulatory authorities. Experience in Change Control and CAPA applications. Demonstrate effective cross-functional and cross-cultural skills. Ability to effectively influence others without direct authority and professionally handle conflict resolution. Ability to independently represent the department in project teams. Demonstrate ability to assess and provide technical and quality guidance to ensure high-quality, compliant devices. Strong skills to organize, prioritize, and execute. Detail-oriented with strong leadership, collaboration, and communication skills.

Quality Manager

Description

Requirements

NextStep Arthropedix