Mackenzie Stuart are working with a globally leading Medical Device Contract Manufacturer on an exciting new opportunity.
The organisations are seeking a Corporate Quality Manager based in New Jersey, US.
Job Details Description Corporate Quality Engineer Are you a Quality professional with a passion for Quality Engineering looking for a new challenge and an exciting opportunity to advance your knowledge, skills and career in a great working environment?
Would you like to have a job that rewards performance and offers competitive compensation and benefits?
I am looking for hardworking and enthusiastic Corporate Quality Engineers to join the Quality Systems team of a key client of mine to help them drive Operational Quality at all manufacturing facilities.
Responsibilities Operational Quality Improvement Execute pilot program activities directed by Quality Systems Manager supporting Operations Manager.
Ensure compliance to program checklist activities and lead corrective actions for errors.
Understand and communicate the performance and quality gains from strict adherence to best practices.
Collaborate cross-functionally to create necessary QMS documents (WIs, PMs, SOPs, Forms) Ensure understanding and training to responsibilities within the plant Quality Department.
Quality Management System (QMS) Support Able to follow applicable requirements of FDA cGMP, ISO 13485, ISO 9001, ISO 14971, FDA 110/210/211, GFSI, Process Validation et.
al.
Create, review, and approve validation IQ/OQ/PQ/PPQ protocols and reports.
Analyze and summarize data for validations, CAPA, and “TPI3” CI initiatives.
Internal Auditing of adherence to procedures.
Manage the Visual Factory Layered Process Audit process and report out on deficiencies and actions.
Monitor impact of plant-floor, process or setting changes on the validated state of the lines.
Create, modify, and approve (with other SMEs) deviations and change control requests for documents, equipment, and processes.
Track open deviations and change controls for proper closure and resolution.
Food & Drug Admin.
(FDA), International Standards Organization (ISO), medical device and pharmaceutical industry best practices.
Identify needs, aid development and presentation of education & training materials with Comar University.
Perform personnel assessments of competency.
Monitor and enforce adherence to clean room/Good Manufacturing Practices (GMP)/industrial hygiene practices.
Consistently deliver messaging about following procedures and fixing issues so they can be followed.
Complete Safety Training Observation Program (STOP) audits and GEMBA (Lean Manufacturing and Kaizen) continuous improvement audits as assigned, ensure Quality Department actions from audits closed.
Develop and maintain personal training plan to stay current on cGMP requirements.
Investigate Customer complaints, Non-Conformance Report (NCR), Corrective and Preventive Action (CAPA), and lead Continuous Improvement Use critical thinking and problem-solving skills to determine root causes of issues (5 Why, Fishbone, 8D, Is/Is-Not).
Lead and/or facilitate Operations and Quality cross-functional investigations.
Determine corrections, corrective actions, and verification of effectiveness.
Analyze data and trends within the CAPA process to determine systemic risks.
Lead corrective action effort for systemic risks.
Document investigations and improvements using analysis of data (ANOVA, Cpk, Trending, etc.) Identifying opportunities for Continuous Improvement, defining value and implementation.
Requirements Bachelor’s degree completed for technology, engineering, science or significant applicable experience, training, and certifications.
Minimum 2 years’ experience in Manufacturing or Quality Engineering.
Experience with Technical writing of reports, data analysis, customer response correspondence, and procedure manuals.
Preferred Experience working in medical device or food manufacturing environments.
Experience with visual inspection standards and processes.
Experience with performing training for plant-floor personnel.
Experience with the validation of manufacturing and inspection processes.
Knowledge of the safety requirements and complexity of working with automated and semi-automated production and inspection systems in a factory environment.
Knowledge of vision inspection systems, and PLCs (programmable logic controllers for factory automation) preferred.
Knowledge of lean manufacturing principals in a high volume and high complexity environment.
Knowledge with injection molding and plastic assembly processes.
If you fit the above criteria, please apply through LinkedIn.