Quality Lead
Location: In person at Kickr Designs headquarters
We are seeking an experienced and proactive Quality Leader to oversee day to day Quality Assurance operations associated with our general product development and medical device projects. This role will play a key part in the development, implementation, and management of the Kickr Design Quality Management System (QMS) and is critical to ensuring compliance with relevant regulatory requirements in a growing organization. The candidate will assist in efforts to build and refine our internal QMS, serving as document control and promoting a culture of quality across the organization. This role will also play a key part in set up and operations of customer-owned QMS operations for Kickr’s clients.
Requirements
Experience & Education
- High EQ and strong situational awareness
- Bachelor’s degree in Engineering, Life Sciences, Quality Management, or a related field.
- Minimum of 5+ years of experience in quality assurance in the medical device industry.
Technical Skills
- Strong understanding of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other regulatory standards.
- Hands-on experience with design controls, risk management, and validation processes.
- Familiarity with eQMS tools and traceability systems.
Leadership and soft skills
- Excellent attention to detail and problem-solving abilities.
- Strong communication and collaboration skills to work across departments.
- Ability to adapt processes for a small company environment while ensuring scalability.
Preferred Qualifications
- Experience with global regulatory frameworks (e.g., EU MDR, Health Canada).
- Knowledge of statistical tools such as sample size power analysis, Design of Experiments (DOE), Gage Repeatability and Reliability (GRR), Six Sigma, or Statistical Process control (SPC).
Key Responsibilities
QMS Development and Oversight:
- Assist in the build out, implementation, and maintenance of a QMS compliant with ISO 9001, ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
- Revise and improve existing QMS processes, ensuring scalability and effectiveness.
Compliance:
- Prepare and lead internal and external audits, including inspections by regulatory bodies.
- Own quality and regulatory related correspondence between Kickr Design’s clients and appropriate external parties
Document Management:
- Manage key quality documents, such as Standard Operating Procedures (SOP), forms, templates, risk management files, and design and document control records.
- Oversee the identification and management of non-conforming product records (NCR) and Corrective and Preventative Action (CAPA) processes, ensuring timely resolution of complaints.
Product Development Support:
- Ensure design and development engineering teams properly generate Design History Files (DHF), within the Kickr QMS process to ensure regulatory compliance through all product lifecycle stages.
- Serve as internal quality reviewer of project-related documentation across ISO 9001 and 13485 projects.
Supplier Quality Management:
- Conduct supplier evaluations, audits, and performance reviews.
- Establish quality agreements and ensure supplier compliance with applicable standards.
- Collaborate with suppliers to resolve quality issues and implement corrective actions.
Training and Leadership:
- Train and mentor team members on quality processes and regulatory compliance.
- Collaborate with cross-functional teams to embed quality in all aspects of operations.
- Manage and track all training records for the Kickr team.
Continuous Improvement:
- Identify opportunities to streamline quality processes while maintaining compliance.
- Establish metrics and KPIs to monitor and improve QMS performance.
Benefits
- Platinum health insurance, including dental and vision, at no cost to you
- 401(k)
- Kickr covers ~40% of the cost to add dependents to Kickr-provided insurance
- Paid personal development opportunities
- Flexible time off
- Flexible work schedule
- Excellent location in Atlanta’s Upper Westside
- Free t-shirt!
Life at Kickr
At Kickr Design, we are proud of the company culture we have developed over the past few years by hiring awesome people. Engineers that work here can expect to experience the following on the job:
- Around-the-clock access to a fully equipped prototyping studio for hands-on experimentation
- Variety in project size, type, and industry
- Creative, collaborative, multidisciplinary teams led by engineers
- Exposure to cutting-edge technologies and research projects
- A relaxed environment where fun is encouraged
Compensation
- $80,000 – $140,000, commensurate with experience
Ready to join the team?
Notice to Recruitment Agencies and Professional Recruiters:
Kickr Design does not accept unsolicited resumes, CVs, or candidate profiles from third-party search firms, staffing agencies, or professional recruiters. All unsolicited submissions sent to Kickr Design or any of our employees—via email, our career site, or internal communication channels—will be considered the sole property of Kickr Design, free of any fee or financial obligation.
We will not pay a placement or commission fee of any kind for any candidate hired as a result of an unsolicited submission. To be eligible for a placement fee, an agency must have an active, written, and fully executed vendor agreement in place with Kickr Design’s Human Resources/Talent Acquisition department and must have been explicitly assigned to a specific open requisition by our team in advance.
Apply for this position
"*" indicates required fields