About Us
Eosera is a growing, female-led biotechnology company founded in 2015 and based in Fort Worth, Texas. We strive to be the leader in ear care, bringing innovative products to market across the USA. Our products are currently sold in over 26,000 retailers across the nation and online, in places such as CVS, Rite Aid, Walmart, Walgreens, Kroger, and Albertsons.
Eosera was named one of the fastest-growing private companies on the Inc. 5000 list in 2021, 2022, and 2023. We are one of the pioneering companies engaging in Conscious Capitalism and believe business can be a force for good. We are setting a new standard for biotechnology companies by continuing to innovate and develop effective products with lasting impact, prioritizing people over profit, and bringing premium products to market that address underserved healthcare needs. Learn more at: eosera.com
About the Position
Consistency and quality are top priorities for any manufacturer. But even with standards and specifications in place for employees to follow, businesses depend on quality engineers to verify that those standards are always met and that only the best and safest products make it to market. Unlike quality assurance professionals, who monitor the overall process and ensure that a manufacturer produces to spec, quality engineers define, monitor, improve upon, and approve the processes needed to achieve top production standards.
Eosera’s Quality Engineer will play a key role in ensuring that the manufacturing process complies with cGMP, FDA and other regulations and to ensure that quality issues are prevented or timely corrected. Reporting to the Head of Quality, this position will oversee a team including a Quality Manager and a Quality Associate.
This full-time, direct hire opportunity offers a full benefit package, the ability to make a major and positive impact, along with opportunities for professional growth and development. If you have experience in a quality management or engineering role within a healthcare manufacturing environment (especially within the cGMP regulated industry), this could be a wonderful opportunity for you!
Eosera is a fast-developing company, growing the ear category with new product innovation and exceptional commercial execution. As we continue to grow, we make sure to hold our company’s values in mind when making important decisions. We are seeking a Quality Engineer who will champion these 7 key core values:
- People – We value people before profit, always.
- Empowerment – We think everyone has the potential to be outstanding.
- Collaboration – We agree that everyone has something to contribute.
- Growth – We focus on continual improvement of ourselves and our ventures.
- Passion – We have drive and an appetite for excellence.
- Bravery – We believe calculated risk-taking will result in great accomplishments.
- Positivity – We believe happiness is healing.
Key Responsibilities
- Assist in managing and maintaining the Quality System program to ensure compliance to product specifications, customers, and overall Quality System requirements in the manufacturing of OTC Drugs, Cosmetics, and Medical Devices.
- Identify and implement quality improvement initiatives.
- Ensure effective and efficient quality processes and procedures.
- Analyze and document product quality metrics.
- Conduct and monitor quality system audits, including internal and external stakeholders.
- Maintain records of manufacturing processes.
- Provide guidance, support, and training to all departments.
- Ensure that QA functions are compliant with all required cGMP regulations.
- Oversee the document control system, including creation, revision, and approval of specifications and master batch records.
- Direct the final goods, packaging stability program.
- Assist with validation activities, including writing, issuing, and reviewing protocols and reports.
- Manage investigations for product complaints, process deviations and product quality failures and implement corrective actions, and conduct corrections, as necessary.
- Maintain effective communication with Management and relay critical issues and action plans involving the quality assurance areas.
- Maintain metrics and reporting tools that enable monitoring of Key Performance Indicators (KPI’s) progression towards attainment of company’s quality objective.
- Assist with FDA communications as they relate to quality.
- Serve as Quality Management Representative for the organization to internal and external stakeholders.
- Follow all requirements outlined in the Quality Management System.
- Work with minimal up-front guidance and take ownership of work.
- Provide back-up for assigned duties for other members of the Quality team.
- Be a brand ambassador for Eosera, fostering a culture of innovation, exceptionally high standards, and true partnership with team members and all external stakeholders.
Education, Experience & Skills
- Bachelor’s degree in mechanical, chemical, industrial engineering or related field
- 5-7 years of Quality Engineer experience in a healthcare manufacturing environment
- Some experience managing or overseeing the work of others
- Proficient in Microsoft Office Business Suite and technical aptitude for other business software platforms (e.g. NetSuite, Vintara)
- Strong interpersonal skills
- Excellent analytical skills
- Strong problem-solving skills
- Passionate about contributing to a collaborative, peak performance culture
We value diversity and commit to making hiring decisions based upon the skills and character traits that correlate to being successful in this job. We are an equal opportunity employer and we welcome your application!
All candidates must be legally authorized to work in the United States.
