us | Quality Regulatory Engineer in New York, NY

Quality Regulatory Engineer

  • AdhereTech
  • 910 Half Moon Rd
  • New York, NY 10004
  • Full-Time

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About AdhereTech AdhereTech creates custom support programs for patients on the world's most crucial medications. These programs are driven by our award-winning, patented device: the smart pill bottle, which is sponsored by pharma and free for patients. Our intelligent system automatically delivers customized text messages, phones calls, live pharmacist support, and more to promote patient adherence to vital medications. Although we are an IoT company that makes a high-tech medical device, we consider ourselves a software and data company. We are collecting information about how people take their medications that has never before been analyzed on this scale. This allows us to understand patient behavior in ways that were previously impossible, and to continuously improve the patient experience.   About the position The Quality & Regulatory Engineer will be a Q&R generalist that has the capability to be utilized in a variety of Quality & Regulatory functions: such as writing and editing Quality System documents in accordance with ISO 13485, FDA 21 CFR 820 and international standards as well as performing internal and external audits, complaint handling, root cause analysis, product life cycle management, and general problem solving. Ultimately, this role will be responsible for delivering high quality products to our customers and patients. Responsibilities The Quality & Regulatory Engineer must have sufficient Quality and Regulatory experience to have the ability to be utilized in a variety of Quality, Regulatory, and Engineering functions Write Quality System procedures and provide training to applicable employees Understands and is familiar with appropriate standards and how to apply them to products and processes efficiently in a startup environment (including but not limited to ISO 9001, ISO 13485, FDA 21 CFR 820, and IEC 60601) Perform Document Control, Risk Management, Supplier Quality, Verification/Validation, and CAPA duties as required Work with Contract Manufacturer (CM) quality team to ensure products are assembled, tested, and packaged according our Device Master Record Maintain an up-to-date list of SOPs, standards, regulations and technical summary files Maintain Class 1 product registrations and listings through various certified bodies including the FDA, FCC, etc. Evaluate, visit, audit, and continuously monitor existing and new suppliers for product quality Qualifications BS or MS degree Minimum 5 years experience in a medical device development and manufacturing company with a focus on Quality and Regulatory functions Working knowledge of Quality System Regulations and international standards (e.g. 21 CFR 820, ISO 13485, ISO 14971, IEC 60601) required Working knowledge of Design Verification, Design Validation, Process Validation, CAPA and Records requirements and processes experience required Demonstrated technical writing skills Demonstrated competence with Quality System tools and strategies (data analysis, statistical analysis, capability analysis, FMEA, auditing Detail oriented with excellent verbal and written communication skills Bonus ASQ certifications a plus Working knowledge of electromechanical medical devices, wireless consumer products, and/or IoT devices Working knowledge of pharmaceutical drugs and pharmaceutical drug packaging Familiarity with usability and human factors product design Working knowledge of plastic injection molding, printed circuit board electronics, and product assembly Benefits & Compensation Health insurance for you & your dependents Monthly company activities Healthy office food and snacks Unlimited vacation & flexible work hours Pre-tax commuter account 401K Plan Competitive salary and participation in our equity incentive program - provided by Dice

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.