Manager Quality Operations

The Manager of Quality Operations is responsible for managing and maintaining the effectiveness of StimLabs Quality Management System to ensure compliance with applicable regulatory and industry standards, including FDA 21 CFR Part 820, 21 CFR Part 1271, ISO 13485, AATB and other related standards. This position plays a key role in managing quality system processes such as CAPA, Deviation, Complaints, Nonconformances, Training, and Document Control Management. The Manager of Quality Operations partners closely with cross-functional teams in operations, tissue recovery, engineering, regulatory affairs, and product development to ensure timely and effective execution of quality system activities, data integrity, and compliance with company and regulatory requirements. As the Quality Systems Manager, this person is responsible for mentoring their quality team to uphold organizational excellence and product integrity.

KEY RESPONSIBILITIES

The essential functions include, but are not limited to the following: Manages the daily activities of Quality Staff including scheduling and coordinating activities to meet company objectives. Administers and maintains core quality system elements including Corrective and Preventive Action (CAPA), Deviations, Investigations, Nonconformances, Customer Complaints, Training Program Administration, Document Control and Record Management. Lead and perform root cause investigations, trend analysis, and effectiveness checks to ensure Customer Complaints, CAPA and Nonconformance activities are completed thoroughly and on time. Review and approve quality system documentation to ensure compliance with internal procedures and regulatory expectations. Manage complaint handling activities, including investigation coordination, risk evaluation, and regulatory reporting. Manage the Change Control (Process Change Request and Software Change Control programs). Manage and report QMS metrics and performance indicators to executive management for Management Review and continuous improvement initiatives. Provide quality oversight during internal audits, supplier audits, and regulatory inspections, and support preparation and responses to audit findings. Serve as a subject matter expert (SME) for QMS processes and provide training for other departments on quality system requirements. Drive continuous improvement initiatives to enhance QMS effectiveness, compliance, and efficiency. Support the onboarding process of new employees and ensure all quality requirements are met. Provide mentorship, training, and technical guidance to Quality staff. Encourage the development of Quality Assurance staff through evaluation of performance and implementation of performance improvement programs. Lead continuous improvement initiatives to strengthen QMS processes and promote a culture of quality. Liaison/Cross-function between multiple departments within the company including but not limited to: Quality and Regulatory Sector, Operations, Partner Alliance, Legal, Human Resources, Marketing, and Information Technology. Responsible for hiring additional departmental staff as needed to support the needs of the company. Member of StimLabs Internal Audit Team. Participates in daily operations of the Quality department including but not limited to: Manages records management and the Document Control system. Lead or collaborate when applicable, on development of Standard Operating Procedures, Work Instructions, and Forms. Daily management of Deviations, Investigations, CAPAs, Nonconformances, and Complaints. Lead or support Change Control activities where applicable. Assists all departments with investigations and documentation of CAPAs, Deviations, Nonconformance Reports, Complaints and Process Change Requests. Support inspections and audits from regulatory agencies, as needed. Assists in training employees in new tasks/functions. Assist all departments with MasterControl and Infor system inquiries. Other tasks and projects, as assigned by department leadership.

REQUIRED QUALIFICATIONS

Bachelor’s degree in a technical field, with at least seven to ten (7-10) years of Quality Assurance and/or Quality Control experience in a pharmaceutical, medical device, biologic, or a tissue banking FDA regulated facility, or an appropriate combination of education, certification and work experience.

CORE COMPETENCIES

Adaptability & resourcefulness in a small, entrepreneurial environment Sound judgment and the ability to navigate ambiguity with confidence Attention to detail and commitment to data accuracy Proactive communication and stakeholder management #J-18808-Ljbffr StimLabs