About the Position
Eosera is seeking a quality assurance associate to join a small team during an exciting early growth stage with products now being distributed through CVS, Rite Aid, and Amazon. The ideal candidate has a college degree in a related engineering or regulatory discipline and some relevant experience (recent college graduates are encouraged to apply; internship experience is applicable). This is a wonderful career-building opportunity for someone who has an interest in quality assurance, manufacturing, life sciences, and entrepreneurship.
The quality assurance associate reports directly to the CEO and will enjoy being a part of a positive and fun entrepreneurial culture. The new team member will benefit from extensive training and coaching as well as a generous learning and development allowance. Exceptional performance will be rewarded with growth and leadership opportunity as our company expands.
Our interview process is rigorous, just as the job will be, to ensure both you and the team at Eosera have the chance to assess if this role will be a great match for your strengths.
Eosera is a biotech startup company based in Fort Worth, Texas, specializing in developing ear care products and aspiring to a purpose of “healing humans”. Founded in 2015, Eosera is a majority woman-owned company and a supporter of conscious capitalism. Learn more at www.EARcareMD.com.
- Ensure that Eosera’s quality system is maintained and meets regulatory requirements.
- Help develop and implement quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards.
- Support & prepare documentation for all production of products to meet FDA requirements.
- Fulfill requirements and/or requests of any regulatory authority in countries where our products are manufactured and distributed.
- Communicate and report on submission status.
- Review changes to existing products, SOPs, test methods, process changes, design changes, labeling/labels, and field issues.
- Support communication with FDA while preparing responses to deficiency letters and/or questions from regulatory agencies.
- Identify best practices and serve as a change agent that provides a path forward for implementation, measurement and results management.
- Develop and communicate performance metrics in a method and manner that becomes actionable and accountable.
- Maintain certifications and coordinate all management system audits.
- Conduct quality system training programs.
- Be a brand ambassador for Eosera, fostering a culture of innovation, exceptionally high standards, and true partnership with team members and all external stakeholders
- Bachelor’s degree in a related engineering or regulatory discipline
- Working knowledge and understanding of manufacturing process and quality system
- Conscientious, take initiative, and be willing to assume responsibility
- Excellent organizational skills and ability to plan and implement resolutions to problems
- Must have exceptional attention to detail
- Self-motivated and have a strong desire to help others succeed in their jobs
- A personal need to self-improve
- Excellent communication and interpersonal skills