Quality Engineer II - Fairfield, NJ 9/17/2016
JOB DESCRIPTIONAPPLY Position Overview:
Provides technical support to engineering teams for the quality assurance function.
* Ensure Quality System is run by current regulation 21 CFR 820, 803, 806, 807 and ISO 13485.
* Work within Quality to assist in maintaining cGMP compliance for products manufactured, packaged, tested and released.
* Work with R&D on new product launches and commercial projects and ensure they are in line with cGMP requirements.
* Write and review in investigations, CAPAs, FIRs, NCMRs, SCARs, HHEs, Change Notices and any additional QA documentation functions necessary to run the business.
* Ensure adequate follow-up through the implementation of corrective and preventive actions as appropriate.
* Provide support to manufacturing for WIP on the manufacturing floor.
* Support Quality Management during audits and inspections.
* Strengthen quality awareness, throughout the organization, support technical services, and process improvements.
* Ensure that proper document control is handled for facility.
* Review protocols and reports as needed ensuring proper compliance to regulations.
* Support new product development activities through understanding and utilizing the New Product Development System. Key activities include quality strategy development, quality planning tools (FMEAs, Quality Plans, Validation Plans, etc.) and qualification/validation strategy development & execution.
* Chair and/or participate in MRB (Material Review Board) meetings.
* Evaluate new product designs through test protocols and data analysis.
* Engage in associated manufacturing/quality process improvement/development support and perform/participate in qualification/validation activities. Monitor progress using operational metrics.
* Identify and assess new opportunities for improvements to work processes, product, and/or services.
* Coordinate technical activities regarding verifications and validations: including protocol development, synchronization of interdepartmental activities, data evaluation, report writing, and presentations to management.
* Review and provide recommendations regarding product/process qualification/validation and other change control related (CRs) documentation prior to department management final approval.
* Communicate, interact and coordinate quality improvement efforts with Manufacturing, QA, R&D, and engineering management regarding product status, deviations and problems; provides testing and training support to Manufacturing, Engineering and R&D.
* Develop calibration methods and frequencies for new production related gages and equipment.
* This is not an inclusive list of job responsibilities.
* Bachelor's degree in Engineering, Science or related field is required
* 1-3 years of experience in quality assurance, quality engineering or related function is required or MS and at least one year of experience. Experience working in the medical device, chemical or material science industry is preferred.
* Must have familiarity with statistical analysis, the ability to analyze and solve problems, and the ability to communicate effectively across departments
* Demonstrate effective time management and project management skills.
* Proficiency with Microsoft Office Products such as Excel and Word or equivalent software applications is preferred. Intermediate computer skills are ideal
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
Getinge is an EO employer - M/F/Veteran/Disability