R&D and QA Specialist

We have a significant opportunity for a dynamic R&D and QA Specialist in our organization. We are a healthcare company in the process of commercializing our FDA approved products that are setting a new standard in the anti-microbial arena – products that safely and effectively address wound and skin infections, promote wound healing and improve surgical outcomes. The position provides the chance to work with a motivated and high energy team and to contribute to and participate in our success.

Desirable Attributes

• Prior R&D or quality experience preferably in medical device or pharmaceutical industry
• Prior knowledge of FDA QSR 820 and ISO 13485, preferred
• Experience with general laboratory equipment
• Experience with product formulation and wet chemistry is preferred
• Knowledge of how and ability to write, review, and revise Standard Operating Procedure (SOPs)
• Familiarity or experience with Greenlight Guru platform a plus
• Self-driven individual with excellent work ethic and a can-do attitude
• Active learner with the ability to thrive in a fast-paced, results-oriented, start-up environment

Roll Summary

An R&D and QA Specialist plays an important role in supporting the development of products and quality system. This person will support the product research and development by following the design control process and QA documentation. Operates and innovates analytical testing to conduct research and define specifications.

Primary Duties & Responsibilities

1. Perform analytical testing in a shared lab setting. Follow good laboratory practices in a safe manner.

2. Assist in developing quality and inspection SOPs/work instructions.

3. Document all testing records according to requirements.

4. Demonstrates ability to document detailed experiments and associated data.

5. Assist in all phases of design control process and its documentation.

6. Provides input into product design, processes, and testing.

7. Assist in maintaining the Company Quality Management System (QMS) in compliance with ISO 13485 and 21 CFR, part 820.

8. Track and publish R&D and quality metrics.

9. Support the implementation of all GMP programs.

10. Participating and supporting internal and external regulatory and customer inspections.