Our company is seeking a Quality Engineer work closely with business partners utilizing various Quality Engineering tools in the development and manufacture of new products as well the maintenance of current products, materials, and processes. Representative on multi-functional product development teams in matters relating to Quality Engineering and in day-to-day activities supporting manufacturing lines, operator certification program, incoming, in process and finished good inspections, and CME environmental monitoring, all in accordance with applicable regulations and Ethicon written specifications and quality standards

Responsibilities

· Will support design control and process validation activities for new and changed 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 and ensure the development of comprehensive risk management plans and operating procedures for the product and process.

· The Quality Engineer will ensure effective and comprehensive quality strategies.

· Will assist in thorough investigation of quality issues and oversee implementation of effective corrective and/or preventive action.

· This individual will ensure the development and validation of appropriate test methods for design and manufacture of products and components.

· 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.

· Will assess, implement, and monitor process capability for continuous improvement.

· This Quality Engineer may be responsible for leading cross-functional work teams and/or managing QA technicians to include direct daily supervision, performance appraisal, behavioral discipline, professional development and on the job training.

· Provide technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & other regulatory health authorities based on established quality systems.

· Functions as a Subject Matter Expert (SME) for Quality related topics during internal and external audits.

· 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.

· Responsible for communicating business-related issues or opportunities to next management level

· Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable

· Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

· Performs other duties assigned as needed.

EXPERIENCE AND EDUCATION

· 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.

· A minimum of 5 years’ Quality Engineering work experience is preferred, with experience in medical devices, pharmaceutical or other highly regulated industry also preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

· Knowledge of ISO and/or cGMP regulations is preferred.

· New product development experience is preferred.

· Supplier Quality Engineering experience is an asset.

· Sterilization process experience is an asset.

· General knowledge in Quality Systems Regulations (QSR) is an asset.

· An ASQ certification (CQE, CQM, CRE or CQA) is an asset.

· Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.

· Basic knowledge of Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.

· 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.

· Good communication and presentation skills will be needed.

· Maturity and ability to display a high level of professionalism are required.