A medical device client is looking to hire a Quality Manager onsite in Gaithersburg, MD. This position will be responsible for planning, organizing, and overseeing Quality strategy to ensure the timely delivery of safe and effective products that meet all regulatory and compliance requirements. This role will partner with the head of quality to make sure that processes required for the Quality Management System(s) are effectively established, implemented, maintained, and will proactively develop improved processes to comply with the requirements of 21 CFR Parts 820 1271. This person will help lead the Quality team and work closely with the key partners, including Operations, R&D and Regulatory.
Experience Needed:
- BS in a scientific discipline required.
- 3 to 5 years of experience in a quality management role
- Extensive quality experience in a FDA and ISO regulated environment, with specific knowledge of 21 CFR Part(s) 820 and 1271.
- Significant experience in the medical device and pharmaceutical industries in both Commercial and R&D/Product development environments
- Experience with combination products (device/ drug) a plus
- Demonstrated capability in business process/system management and improvement
- Experience interfacing with government and accreditation agencies (FDA, ISO, AATB), managing audits and supporting regulatory filings, responses and other documents required in a regulated environment.
- Experience with analytical drug testing (HPLC, MS, GCMS, UV-Vis, NMR, etc.), interpreting results, and troubleshooting as needed.
Essential Duties & Responsibilities:
- Understand company strategy, anticipate quality requirements, and implement changes or improvements to support business growth
- Manage/oversee Quality Assurance responsibilities related to Operations, Quality Systems and Quality Engineering activities.
- Help the Quality Leader manage the quality org by building out a team for the Gaithersburg, MD facility
- Establish and implement the quality systems to comply with regulatory requirements, including FDA QSR (21 CFR 820 and 1271), ISO 13485, CMDCAS, etc. as applicable to Elutia business requirements.
- Establish capabilities as needed to ensure quality standards are met and compliance requirements are consistently achieved throughout organization.
- Communicate status of the quality system to senior leadership using established metrics and reports.
- Lead or participate on multidisciplinary teams for new product development and/or to resolve complex product investigations.
- Manage, interact, and engage with FDA, notified bodies, and international regulators during on-site audits / inspections, field actions, recalls, or post market surveillance/vigilance activities.
- Engage with key external partners (e.g., vendors and consultants) on Quality priorities, process improvements, validations, etc.
Salary of $120-150K + bonus and benefits