We are looking for a full-time quality assurance engineer with medical device experience. This position offers a unique opportunity to implement and improve a developing quality management system while working directly with a multidisciplinary team to bring high-quality, innovative products from concept to commercialization. The ideal candidate has experience/training with medical device quality requirements, including 21 CFR 820 and ISO 13485. Most importantly, candidates must be ready to put their skills, organization, attention to detail, and knowledge to use in developing medical devices that will define the future of medicine and benefit people around the world.
Responsibilities:
-Implement existing standard operating procedures (SOPs) and establish new or improved procedures to balance quick innovation with strong quality practices
-Assist in medical product and process verification and validation activities
-Assist in medical device design & development and risk management activities
-Identify applicable international and/or FDA-recognized consensus standards, maintain a standards library, and coordinate with R&D team to ensure requirements are met
-Manage purchasing and receiving processes
-Manage supplier evaluation, approval, and auditing program
-Coordinate inventory management with R&D team
-Conduct internal audits
-Identify and execute nonconformities and corrective/preventive actions (CAPAs)
-Develop the general Quality Management System to meet ISO 13485 requirements
Qualifications:
-B.S. degree in Engineering, Scientific, or Business field
-7+ years of experience in engineering, business, or medical
-Working knowledge and experience with 21 CFR 820 and ISO 13485 requirements
-Familiarity with international standards and FDA guidance documents for medical electrical equipment
-Excellent organization and attention to detail
-Strong communication and problem-solving skills
-Ability to work independently with minimal supervision
-Fast, adaptable learner
What we offer:
-A unique opportunity to drive a revolution in medical practices and to significantly improve the health condition of patients
-A unique environment for you to exercise your talents and be impactful
-Medical, dental and vision insurance
-Employee stock option
Last but not least, we are a small team and thus everyone plays a critical role - your voice will be heard clearly and loudly! Come join us and build the future, today.
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