The Quality Engineer will work closely with business partners utilizing various Quality Engineering tools in the manufacture of new products as well the maintenance of current products, materials and processes. This individual will function as a quality representative on multi-functional teams in matters relating to Quality Engineering. Will support design control and process validation activities for new and change product efforts. This individual will 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. This individual will lead the review of risk management plans and operating procedures for the product and process. The Quality Engineer will provide oversight for effective quality strategies. Will assist in thorough investigation of quality issues and oversee implementation of effective corrective and/or preventive action. The Quality Engineer will track/trend quality issues over time and generate reports to management and across sites. This Quality Engineer will provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as medical device regulations.
Provide technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems. Provide support to J&J process excellence initiatives including Six-sigma & lean thinking. Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations. Ensure compliance with company policies and procedures.
EDUCATION, EXPERIENCE, & SKILLS
1. A minimum of a Bachelor's degree in Engineering, Life Science, Physical Science or a related field is required; an advanced degree is an asset.
2. A minimum of 2 years Quality Engineering work experience is preferred, with experience in the medical device, pharmaceutical or other highly regulated industry also preferred.
3. Knowledge of ISO and/or cGMP regulations is preferred.
4. New product development experience is preferred.
5. Supplier Quality Engineering experience is an asset.
6. Sterilization process experience is an asset.
7. General knowledge in Quality Systems Regulations (QSR) is an asset.
8. An ASQ certification (CQE, CQM, CRE or CQA) is an asset.
9. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
10. Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.
11. 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.
12. Good communication and presentation skills will be needed.
13. Maturity and ability to display a high level of professionalism is required.
14. The ability to work some nights/ weekends/ holidays may be required.