The Ethicon business offers a broad range of products, platforms and technologies including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Based in Somerville, New Jersey, Ethicon Inc. was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery Inc., which was created 20 years ago, in Cincinnati, Ohio, develops innovative devices that have driven the revolutionary shift from open to minimally invasive surgery and continues to lead this industry today.
Duties & Responsibilities
The Associate Quality Engineer will participate in a range of initiatives within the Wound Closure business including:
- Serve as the Quality lead on multi-functional product development teams in matters relating to Quality Engineering supporting sutures, meshes, needles, tissue skin adhesives, and combination products.
- Support and Lead life cycle management activities including product design changes, updates to risk documentation, complaint trending, assessment of quality signals, remediation activities, and integration of regulations such as the EU MDR.
- Support design control and process validation activities for new products and change products.
- Partner with more senior Engineers to ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sampling plans.
- Lead and ensure the development of comprehensive risk management plans for the product and process.
- Ensure effective and comprehensive quality strategies.
- Ensure the development and validation of appropriate test methods for design and manufacture of products and components
- Assist in thorough investigation of quality issues and effective corrective and/or preventive action.
- Provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as medical device and/or combination products regulations.
- Identify areas of opportunity for improved customer experiences through the evaluation of available post-market customer data and trending of complaint data.
- Participate in cross-functional teams towards the implementation of a combination products program in compliance with 21CFR part 4 (FDA Regulation for combination products).
- Support the development of combination products including elements of pharmaceutical GMP’s such as annual product stability, tracking of drug degradation, establishment of yield targets, supporting cleaning validations, and developing sampling plans for the inspection of reserve samples.