This is your opportunity to join a true medical device startup in a high-impact quality engineering role. This is a fit for an entrepreneurial-minded engineer with quality experience that can lead QC and operational elements of the company and can critically ensure the quality and operational excellence of our medical device manufacturing processes. The ideal candidate will possess a strong background in quality control, regulatory compliance, and operational management within the medical device industry. There is a high interest for candidates with patient monitoring device exposure and regulatory experience.
Responsibilities:
- Develop and maintain the quality control system to ensure compliance with regulatory standards (FDA and ISO) and implement best practices for quality control of components and finished devices.
- Manage and lead the quality control team to ensure high product quality. Identify what is required to achieve objectives.
- Oversee the day-to-day operation of the QC function at the company.
- Establish and maintain quality assurance procedures, standards, and specifications.
- Conduct regular internal audits and coordinate external audits as required.
- Analyze quality control data to identify trends, issues, and opportunities for improvement.
- Lead process development, qualification, and validation efforts for the company.
- Stay up to date with evolving regulations and standards in the medical device industry.
- Ensure the company's compliance with all applicable regulatory requirements, including FDA submissions and audits.
- Act as the primary point of contact for regulatory agencies, including serving as the QMS representative.
- Recruit, train, and develop a high-performing team, promoting a culture of continuous improvement and quality excellence.
- Set clear performance expectations and provide regular feedback and coaching to team members.
- Prepare and present regular reports on quality control metrics and operational performance to senior management.
Requirements:
- BS in Biomedical Engineering, Operations, or related field and 5+ years of experience in quality control in the medical device industry.
- In-depth knowledge of quality management systems, ISO standards, and FDA regulations. Experience with Software Development Life Cycle and maintaining a design history file for electrical devices, firmware, and algorithms.
- Strong analytical skills with the ability to interpret data and drive process improvements. • Excellent leadership and team management skills.
- Effective communication and interpersonal abilities.
- Proven experience in managing cross-functional teams and working collaboratively with other departments.
- Exceptional problem-solving skills and attention to detail. Ability to lead the drafting, review, release, and implementation of new processes and procedures with limited oversight or guidance.
- Experience in human subjects testing and wearable sensors, preferred.
- Experience with clinical validation studies, preferred.
- Experience with regulatory submissions and audits, preferred.
- Experience with operations, preferred.
- Certified Quality Engineer (CQE) certification, preferred.
- Experience with lean manufacturing and Six Sigma methodologies, preferred.
Compensation: Competitive Based on Experience
Travel: Minimal
Years of Experience: 5+
Degree: BA/BS
Location: Atlanta, GA
This job description is not exhaustive and may have been condensed for online or mobile viewing. It does not encompass all duties, responsibilities, or aspects of the job, and is subject to amendments at the sole discretion of the Employer. Employees may also perform other related duties as negotiated to meet the organization’s ongoing needs.
Legacy MedSearch was named to the 2019-2024 Forbes list of Best Recruiting Firms in America.