Johnson & Johnson Careers
Primary Quality Engineer - New Product Introduction/Life Cycle Management
Requisition ID: 7982190620
Ethicon is currently recruiting for a Primary Quality Engineer - New Product Introduction/Life Cycle Management to be a part of a team supporting New Product Introductions, Combination Products, and Life Cycle Management activities to be located at Somerville, NJ.
We, Ethicon, offer a broad range of products, platforms and technologies including sutures, topical skin adhesives, and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. We are looking for our next team member!
You, the Primary Quality Engineer, will participate in a range of initiatives within the Wound Closure business serving as the Quality lead or sub-lead on multi-functional product development teams in matters relating to Quality Engineering supporting sutures, meshes, needles, tissue skin adhesives, and combination products. As a Primary Quality Engineer, your main responsibilities include:
- Ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development and validation, statistical data analysis, sampling plans, failure investigations, and corrective/preventive actions.
- Improve the sustainability of the combination products program by coming up with creative ideas to for process improvements.
- Lead the creation of quality strategies and support design control and process validation activities for new and changed products.
- Engage with project teams, suppliers and other disciplines to ensure compliance with company policies, procedures, and government regulations.
- Identify areas of opportunity for improved customer experiences through the evaluation of available post-market customer data and signal assessments.
- A Bachelor's degree in Engineering, Life Science, Physical Science or a related field is required
- A Master’s Degree is preferred.
- A minimum of 2 years of relevant industry experience in an FDA regulated industry for Medical Devices, Biologics, or Pharmaceuticals is required.
- MS computer skills including Power Point, Word, and Excel are strongly preferred.
- A fundamental knowledge of Quality Systems Regulations (including Design Control), Combination Product Regulations, and Product Risk Management following ISO14971 or ICH Q9 is required.
- Basic knowledge of GMP’s and related ICH guidance required
- Prior experience working with polymers or adhesives required.
- Proven leadership and/or participation in campus/community service activities strongly preferred.
- Position location: Somerville, New Jersey
- You many need to travel up to 25% of the time including domestic and international locations.
United States-New Jersey-Somerville-
Ethicon Inc. (6045)