Johnson & Johnson Careers
Senior Quality Engineer, New Product Introduction / Lifecycle Management
Requisition ID: 2216180917
- 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 design control and process validation activities for new products and change products.
- 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.
- 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.
- A minimum of a bachelor’s degree in Engineering, Life Science, Physical Science or a related field is required; A Master’s Degree is preferable
- A minimum of 4 years of Quality Engineering or related work experience in FDA regulated industry for Medical Devices, Biologics, or Pharmaceuticals is required
- MS computer skills including Power Point, Word, and Excel are required.
- Intermediate knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is required
- Candidate must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Purchasing, Marketing and Medical Affairs.
- This position may require up to 25% domestic (US) and International travel.
- Strong knowledge of Quality Systems Regulations including Design Control and Product Risk Management following ISO14971 or ICH Q9 is preferred.
- ASQ certification (CQE, CQM, CRE or CQA) preferred
- Knowledge of pharmaceutical GMP’s and related ICH guidance is preferred.
- Experience working with polymers or adhesives is preferred.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Somerville
Ethicon Inc. (6045)