Quality Manager (Tissue)

Title: Quality Manager (Tissue)

Location: Gaithersburg, MD

Status: full-time direct hire- Onsite Monday through Friday

Compensation: $120,000 per year.

This position requires direct experience in an FDA-regulated environment with human tissues or tissue-based products (HTC/P) and knowledge of 21 CFR part 1271.

Additional experience in Commercial Stage Medical Device is also required.

The Manager of Quality Assurance & Quality Control is responsible for overseeing and maintaining the quality system and process compliance activities, daily, including the monitoring of inspectional activities and dispositioning of non-conforming products. Interacts directly with internal and external customers on product release activities as needed. In addition, this individual will play an integral role in coordinating activities across departments to achieve desired growth and establish corporate goals in an entrepreneurial environment. For example, this leader will partner with operations to ensure compliance with applicable procedures. This position will be located on-site in the Company’s Gaithersburg, MD facility.

Essential Duties & Responsibilities

• Review and approve applicable document change orders.
• Assist management in developing strategic regulatory approaches for new product/business development.
• Oversee the day-to-day activities related to the quality and safety of tissue products and processes.
• Establish and assist with the implementation of quality systems and system improvements.
• Ensure necessary corrective and/or preventive actions are taken in accordance with established procedures.
• Lead continuous improvement activities.
• Monitor regulations, standards, policies, and guidance issued by relevant regulatory authorities for changes that may impact the company and disseminate information accordingly.

Education & Experience:

• BA or BS in the life sciences or a related degree program
• A minimum of 5 years in a management role with extensive quality experience in an FDA-regulated environment, with knowledge of 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products (HTC/P) preferred.
• Experience successfully interfacing with accreditation agencies (ISO, AATB), writing responses and other documents required in a regulated environment.
• Strong leadership skills; demonstrated ability to clearly develop and articulate short-term goals and objectives to drive performance and results
• Ability to juggle multiple tasks and prioritize work appropriately with a focus on timelines and deliverables • Strong communication (written, oral and interpersonal) and presentation skills.
• Must have demonstrated experience presenting to diverse audiences including Internal (leadership team, employees) and external (Company executives, operations & purchasing teams)
• Excellent judgment and decision-making capabilities; must be able to formulate business solutions to a myriad of challenges