Johnson & Johnson Careers
Senior Quality Engineer, New Product Development
Requisition ID: 2145180524
Johnson & Johnson’s Neurovascular Division (CERENOVUS), a member of the Medical Device group within Cardiovascular & Specialty Solutions (CSS) is recruiting for a Senior Quality Engineer, New Product Development to be located in Miami, FL.
The Cardiovascular & Specialty Solutions (CSS) Group consists of six diverse businesses aside from Neurovascular which serve a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Surgical and Non-Surgical Aesthetics, and Reprocessing.
Johnson & Johnson’s Neurovascular (CERENOVUS) Division is one of the leaders in the medical device industry. Our implants and instruments are used by interventional neuroradiologists, neurosurgeons and neurologists, to treat patients with conditions resulting from hemorrhagic and ischemic stroke. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding. We are one of the fastest growing businesses within Johnson & Johnson.
You, the Senior Quality Engineer, New Product Development represents the Quality Engineering function on product development teams supporting activities during various stages of a product’s life cycle. You will ensure that either new product development or sustaining engineering projects are conducted in compliance with internal, customer, and regulatory requirements.
You, Senior Quality Engineer, New Product Development works in a design team setting where you will support design control activities for new product development efforts, including design transfer. He/she will develop risk assessment; inspection methodology and acceptance criteria for inspection sample plans. You will have the opportunity to provide leadership in the understanding of medical device regulations to other disciplines. You should be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing.
You, the Senior Quality Engineer, New Product Development participates in component and service supplier evaluation, including supplier audits, if applicable. This individual works with suppliers to ensure appropriate quality controls are implemented. The individual in this position will be expected to review lot documentation and release product for clinical use, as well as taking leadership in audits of Design History Files. We need you to guide product development teams on efficient and effective application of design controls and risk management.
- A minimum of a Bachelor Degree is required.
- A degree in an Engineering or Scientific discipline is preferred.
- An Advanced Degree in a related field is an asset.
- A minimum of 4 (work, internship, co-op, etc.) years of experience in a regulated industry is required.
- Familiarity with inspection methods and sampling techniques as well as a proficiency in test method validation is required.
- Excellent problem solving/root cause investigation and decision-making skills is required.
- Experience working on cross functional teams is required.
- Experience conducting Failure Mode Effects and Analysis is required.
- Familiarity with ISO 14971:2012 Risk Management standard is preferred.
- Ability to work in a special environment such as a clean room is required.
- Ability to work with and operate specialized pieces of equipment is preferred.
- Ability to wear protective garb such as lab or clean room gowns is required.
- This position will be located in Miami, FL and may require up to 15% - 20% domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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