QA Engineer III

- Advanced degree with a minimum of 3 years of experience, or a Bachelors degree with at least 5 years of experience in quality assurance within a regulated industry (pharmaceutical, medical device, or biotech) or a relevant mix of skills and experience. - Preferred areas of study include Engineering, Life Sciences, Chemistry, or related technical fields. - ASQ certifications (CQE, CQA) are preferred. - In-depth knowledge of cGMP, ISO 13485/9001, and relevant regulatory requirements (FDA, EMA, etc.). - Proficient in quality systems such as Design Control, Change control, Risk management, and FMEA. - Familiarity with document control processes. - Experience in internal and external auditing. - Advanced problem-solving and root cause analysis capabilities. - Strong project management skills. - Excellent verbal and written communication abilities. - Proficiency in quality management software and MS Office. - Experience with validation and qualification protocols. - Knowledge of statistical analysis and quality tools. - Capability to work both independently and collaboratively. - Attention to detail while maintaining a broader perspective. - Excellent interpersonal skills for effective cross-functional collaboration. - Must be legally authorized to work in the United States without sponsorship. - Must successfully pass a comprehensive background check, including drug screening.