Quality Assurance Specialist
Frida
- Miami, FL
- Permanent
- Full-time
- Maintain QMS procedures, forms, records, and training; ensure controlled documents are current and effective.
- Manage filing, access, retrieval, and retention periods for records and documents.
- Review Quality System Records for conformance and compliance.
- Author, review, and approve SOPs, work instructions, forms, and controlled logbooks.
- Execute product release activities, verify required documentation, manage holds and dispositions, and escalate deviations as needed.
- Establish and improve product and process quality through individual and team-based problem-solving using industry best practices.
- Prepare for and participate in internal and external audits and inspections; track findings to closure.
- Identify opportunities for improvement, recommend solutions, and drive implementation.
- Collaborate with Engineering and Quality departments during product development to ensure compliance throughout design and manufacturing processes.
- Review Engineering Change Orders related to design, engineering, or manufacturing.
- Partner with internal auditors and quality managers on compliance-related matters.
- Provide support on development projects and regulatory issues to ensure timely submissions for market clearance.
- Collaborate cross-functionally to drive continuous improvement in yield, defect reduction, and customer experience.
- Bachelor’s degree in engineering, Science, or another technical field.
- 2+ years of relevant experience, ideally within the medical device, cosmetics, or other regulated industries.
- Familiarity with regulatory requirements (e.g., FDA, ISO 13485, GMP) strongly preferred.
- Energetic, positive team player who thrives in an entrepreneurial environment.
- Strong advocate for product excellence and quality.
- Analytical skills with the ability to make data-driven decisions and communicate effectively.
- Highly organized with the ability to manage multiple priorities and tasks with strong attention to detail.
- Ability to identify opportunities, recommend improvements, and implement solutions.
- Strong written and verbal communication skills.
- Robust health benefits including:
- Comprehensive medical, vision, and dental plans
- Employer paid life insurance
- Supplemental insurance options including Accident Insurance, Short-Term Disability and Long-Term Disability
- FSA & HSA
- 401k matching up to 4% with immediate vesting.
- Generous paid time off program including elective PTO days, federal holidays, sick/wellness days, and a birthday floater.
- Flexible paid pregnancy and parental leave.
- Weekly wellness programming designed to maximize personal time and minimize time spent investing in personal care outside of work hours. This includes a variety of programming such as in-office manicures & pedicures, blowouts, massages, and carwash services.
- Dog friendly office - feel free to bring your best buddy with you to work!
- Learning & development opportunities for professional and personal growth
- Company-wide events & outings. Team engagement is at the center of our culture. This ranges from small department-specific teambuilding or informal outings to our annual Fam Jam family carnival that celebrates the people in your life who support you in bringing your best self to work each day. We also host an annual Day of Service to support our local Miami community, and provide a variety of volunteer opportunities throughout the year that support our mission to serve parents and children.
- Exclusive employee product discounts.