Our client is a dedicated Austin-based, private equity-funded, medical device company that offers an innovative, FDA EUA-authorized, rapid PCR, point-of-care system. Their product is easy to use, affordable, and provides PCR results in only 15 minutes. They have a vision to enable simple, affordable, rapid, and accurate testing for everyone. They are an incredibly talented and diverse team of scientists, engineers, and experienced professionals who are driven to excel and make a significant contribution to the world!
As they continue to grow exponentially, they are looking for a Quality Engineer to contribute to the establishment and upkeep of the company’s quality management system. This position involves providing ongoing support for quality operations and supplier quality initiatives. The Quality Engineer will collaborate with the Operations, Engineering, and Assay Development teams, as well as the company’s suppliers and vendor partners, to ensure that the company’s products adhere to the highest quality standards and comply with all relevant regulations.
What’s in it for YOU?
- They offer a fast-paced, exciting, collaborative environment where individual contributions are highly valued as they work to expand the use of transformative testing technology in the market.
- A wonderful company culture with great core values and looking for team players who also align with them – Value Everyone, Ownership, Innovation, Collaboration, and Excellence Driven!
- Very exciting time to work with an awesome leadership team that has proven experience commercializing biotech, including expertise in system and assay research and development, regulatory, intellectual property, engineering, and manufacturing.
- This company is in growth mode and is bound for great things! This is an opportunity for you to help make a significant difference with this delivery to the world!
What YOU get to DO at this growing company:
- Ensures compliance with 21 CFR Part 820, ISO 13485, and other relevant regulations by providing support through the interpretation of regulations and the authoring of procedures.
- Supports the development and maintenance of document control, change control, training, inventory management, and calibration/maintenance systems, while performing necessary administrative duties.
- Ensures that the manufacturing and testing of medical device IVDs align with company procedures and adhere to Good Manufacturing Practices (GMPs).
- Reviews and approves manufacturing and testing/inspection records, authorizing product release.
- Provides support for the generation/approval of documents related to design control, process, and system verification and validation.
- Assumes a leadership role in cross-functional teams for root cause analysis investigations, resolutions, and product disposition activities; approves non-conformance reports/CAPA records.
- Supports calibration and maintenance activities, as well as process validations.
- Collects, analyzes, and reports Quality System data to drive improvements to the Quality Management System (QMS).
- Facilitates the company’s supplier quality management program and guides cross-functional partners through supplier selection, audit, change control, and qualification processes.
- Executes quality responsibilities in complaint handling and reporting to regulatory authorities.
- Performs internal audits and provides support for external 3rd party inspections/audits.
- Undertakes additional duties and responsibilities as assigned by management.
What you NEED to SUCCEED in this challenging role:
- Bachelor’s degree in engineering, Science, or a related field.
- A minimum of 3 years of experience in a quality, operations, engineering, or related role within a CFR 820 and ISO 13485-2016 cGMP environment.
- Strong written and verbal communication skills, with the ability to effectively train others in quality principles and operations.
- Certification as a Certified Quality Engineer (CQE) is desirable.