Quality Regulatory Engineer


: $97,590.00 - $144,930.00 /year *

Employment Type

: Full-Time


: Engineering

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AdhereTech is a patient support company (powered by software & data) located in downtown New York City - and we are changing how patients take and manage their most crucial medications. AdhereTech is able to partner with the world?s largest healthcare companies to improve care for tens of thousands of patients, every day. Within the past year, data has been published by three of the largest healthcare companies in the US, proving that AdhereTech benefits all patients, especially those with serious diseases like cancer, auto-immune disorders, rare diseases, and more: www.AdhereTech.com/Evidence 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 7 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 Why You Should Join Us Sunny new office located in downtown Manhattan with gorgeous views of the Hudson River and Statue of Liberty Competitive base salary and participation in the company equity plan Medical, dental, and vision benefits for you and your family Access to pre-tax commuter benefits Company sponsored 401(k) plan Flexible vacation policy Fully stocked office snacks Fun and exciting team events Dog friendly Fridays
Associated topics: dsp, electric, electrical engineer, kv, lighting, msee, power, renewable, rf, signal processing * 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.

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