What are the responsibilities and job description for the Quality Assurance Engineer position at JALEX Medical, LLC?
Job Description
The successful candidate for this position will have direct support from leadership and team members through training and continuous learning. The individual will be responsible for identifying regulatory classification and designation, preparing premarket submissions, communicating with regulatory agencies, developing Quality System procedures, and performing internal and supplier audits.
Essential Responsibilities:
• Identifying regulatory classification and designation per relevant regulations, guidance documents, international standards, or consensus standards.
• Preparing premarket FDA and international regulatory submissions with technical review of data and reports.
• Communicating with regulatory agencies via pre-submissions and responses to premarket submission requests.
Required Skills and Qualifications:
• Bachelor's Degree in Engineering, Science, or health-related field.
• 2 years' related work experience in the medical device industry.
• Working knowledge of FDA and other regulatory authorities.
• FDA Regulatory submission experience (Pre-Submission, 510ks, PMAs, IDEs).
Qualifications:
• Self-starter, self-motivated, and results-oriented.
• Excellent interpersonal and written communication skills with high attention to detail in written work.
• Ability to work independently and with cross-functional internal and external teams.
