Senior Director, Quality

Cerapedics, Inc.•Westminster, CO

8h•Onsite

About The Position

Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world-wide. Cerapedics’ product, i-FACTOR, is FDA PMA approved for cervical use in the United States. Cerapedics’ next-generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO. Healing lives through bone repair – this mission is what inspires us every day. If that is inspiring to you as well, consider joining us as a Senior Director, Quality in our Westminster office. In this role, you will contribute to our mission through leading and strengthening our quality organization that ensures safety, effectiveness, and regulatory compliance of our products as we grow. As a Senior Director, Quality working on the Quality team, you will be empowered through meaningful work and career development to establish product quality and compliance strategies, directing the development, implantation, and management of a comprehensive quality system and service as key quality leader and representative.

Requirements

10 years of progressive work experience growing and developing quality systems in a mid-size medical device or a combination of medical device and pharmaceutical industry experience.
At least 7 years of previous management experience.
Minimum of a bachelor’s degree in scientific or engineering technology; other technical degrees may be considered.

Responsibilities

Providing hands-on leadership to the Quality team
Monitoring and ensuring compliance with FDA, ISO 13485, and global quality requirements
Reviewing and resolving quality issues arising from manufacturing and quality processes
Supporting inspections and audits
Partnering cross-functionally to ensure product quality and support continued business growth
Demonstrates effective leadership for the Quality organization while driving initiatives and global vision, strategic planning to fulfill organizational objectives.
Develops, implements, and oversees a Quality Management System that complies with domestic and international regulations and standards for drug and/or medical devices.
Oversees customer product complaint program and follows up with appropriate action to ensure quality compliance.
Responsible for Management Review process to assess the effectiveness and compliance of the quality system programs and related operations.
Ensuring compliance with the validation program that includes the processes, equipment, test methods, etc.
Directs the writing and implementation of procedures and specifications to ensure an effective Quality System that complies with applicable regulations and standards.
Reviews processes and systems on an ongoing basis to determine where improvements can be made for operational efficiency and to ensure continued compliance with regulations and standards.
Ensure that risk management processes are defined in SOPs and effectively implemented throughout the quality system.
The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured before a device is released.
Strategically ensures quality objectives are established and in alignment with business objectives, and that the objectives are continually monitored to ensure targets can be achieved.
Frequently communicate and interact with all departments including manufacturing, R&D and commercial partners with regards to quality issues.
Provide Quality representation in product development and process improvement projects, providing input regarding quality issues.
Support company goal setting and monitoring, budgetary spending and collaboration
Manage the quality system department personnel.
Highly experienced in training, assigning and prioritizing work duties, monitoring work output and efficiency, and providing appropriate performance management and reviews to ensure the effectiveness of the team under our operational values.
Plan for future departmental staffing and other resource needs to ensure they are adequate to accommodate company expansion and goals.
Hires, trains, schedules and supervises the effectiveness of the Quality staff, manages daily activities and scheduling appropriate to ensure business continuity.
Provides leadership, and coordinates closely with cross-functional teams to ensure quality activities are aligned to maximize efficiencies and scheduling requirements.
Direct and ensure accountability that testing and documentation activities are scheduled and fulfilled in a timely manner concurrent with operational goals.