Senior Quality Engineer

Comar•Buena, NJ

48d

About The Position

Senior Quality Engineer “Come build a Career with our Growing, Fast-Paced, Customer-Focused Company that fosters Training & Professional Development!” Are you a Quality Engineering professional 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? We are looking for a hardworking and enthusiastic Quality Engineer II to join our Corporate Quality dream team and help us drive operational excellence throughout our facilities. THE ROLE Operational Quality Improvement Through Corporate Programs Drive Operational Quality Improvement through corporate programs that implement cGMP and Comar's TPI 3 methodology. Execute pilot program activities directed by Quality Systems 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, Standard Operating Procedures (SOPs), Forms, etc. Ensure understanding and training to responsibilities within the plant Quality Department. Quality Management System (QMS) Define processes, validations, and maintain the validated state of Production. Follow, correct, and create necessary documents and processes to meet QMS requirements. Learn and follow applicable requirements of FDA cGMP: ISO 13485, ISO 9001, ISO 14971, FDA 110/210/211, GFSI, Process Validation, and others. Create, review, and approve validation IQ/OQ/PQ/PPQ protocols and reports supported by subject matter experts (SME's). Analyze and summarize data for process validations, Gage repeatability and reproducibility (GR&R), Test Method Validation (TMV), Corrective and Preventative Actions (CAPA), and Comar initiatives. Conduct internal auditing of adherence to procedures. Participate in Quality Circles and the Layered Process Audits 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. FDA, ISO, Medical Device and Pharmaceutical Industry best practices Improve plant-floor understanding and compliance in FDA, ISO, medical device, and pharmaceutical industry best practices. Identify needs, aid development and presentation of education & training materials within Comar's Learning Management platform, Comar University. Perform personnel assessments of competency. Monitor and enforce adherence to clean room, cGMP, and industrial hygiene practices. Consistently deliver messaging about following procedures and fixing issues so they can be followed. Complete STOP audits and GEMBA audits as assigned, ensure Quality Department actions from audits closed. Develop and maintain personal training plan to stay current on cGMP requirements. Drive Continuous Improvement in processes and systems Investigate Root Cause and Corrective Actions for Complaints, Non-Conformance Reports (NCRs), CAPAs. Investigate sources of nonconformances using structured root cause analysis industry practices. 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 or undergraduate senior in Engineering, Technology, Science, or significant applicable experience, training, and certifications.
At least 5 years of Quality Engineering experience or other Engineering discipline in a Manufacturing environment.
Experience with technical writing of reports, data analysis, customer response correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers and cross-functional co-workers.
Ability to define problems, collect data, establish facts, and draw valid root cause conclusions based upon data.
Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Ability to read technical drawings, dimensions, tolerancing.
Skilled at learning the use of computerized systems: PC-based and/or equipment-based Human-Machine Interfaces (HMI's), Graphical User Interfaces (GUI's) for production and inspection equipment.
Knowledge of Regulated Industry: CFR Part 820 Quality System Requirements, the ISO family of standards, particularly ISO 13485 and 9001, others as the corporation certifies to them.
Ability to interpret input from technical staff and Engineering to apply risk-based thinking on the proposed activity or change to a process or equipment.
Ability to interact with manufacturing associates in a meaningful way to ensure collaboration and trust.
Experience with Geometric Dimensioning and Tolerance (GD&T), Measurement Systems Analysis (MSA), and Failure Modes and Effects Analysis (FMEA).

Nice To Haves

Quality certifications in Quality Management or Quality System Auditing, i.e., CQM Certified Quality Manager, CQE Certified Quality Engineer, Certified Quality Auditor, CSSBB Certified Six Sigma Black Belt.
CMfgE Certified Manufacturing Engineer.
Experience working in medical device or food/food packaging manufacturing environments.
Experience with visual inspection standards and processes and experience with the validation of manufacturing and inspection processes.
Experience with performing training for plant-floor personnel.
Experience in developing and instituting visual management, Total Quality Management (TQM), Total Productivity Management (TPM), Lean Six Sigma Methodology.
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 programmable logic controllers (PLC) for factory automation.
Knowledge of lean manufacturing principals in a high volume and high complexity environment
Knowledge with injection molding and plastic assembly processes
Experience in cGMP and CFR Part 820 Quality System Requirements, the ISO family of standards, particularly ISO 13485 and 9001.

Responsibilities

Drive Operational Quality Improvement through corporate programs that implement cGMP and Comar's TPI 3 methodology.
Execute pilot program activities directed by Quality Systems 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, Standard Operating Procedures (SOPs), Forms, etc.
Ensure understanding and training to responsibilities within the plant Quality Department.
Define processes, validations, and maintain the validated state of Production.
Follow, correct, and create necessary documents and processes to meet QMS requirements.
Learn and follow applicable requirements of FDA cGMP: ISO 13485, ISO 9001, ISO 14971, FDA 110/210/211, GFSI, Process Validation, and others.
Create, review, and approve validation IQ/OQ/PQ/PPQ protocols and reports supported by subject matter experts (SME's).
Analyze and summarize data for process validations, Gage repeatability and reproducibility (GR&R), Test Method Validation (TMV), Corrective and Preventative Actions (CAPA), and Comar initiatives.
Conduct internal auditing of adherence to procedures.
Participate in Quality Circles and the Layered Process Audits 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.
Improve plant-floor understanding and compliance in FDA, ISO, medical device, and pharmaceutical industry best practices.
Identify needs, aid development and presentation of education & training materials within Comar's Learning Management platform, Comar University.
Perform personnel assessments of competency.
Monitor and enforce adherence to clean room, cGMP, and industrial hygiene practices.
Consistently deliver messaging about following procedures and fixing issues so they can be followed.
Complete STOP audits and GEMBA audits as assigned, ensure Quality Department actions from audits closed.
Develop and maintain personal training plan to stay current on cGMP requirements.
Investigate Root Cause and Corrective Actions for Complaints, Non-Conformance Reports (NCRs), CAPAs.
Investigate sources of nonconformances using structured root cause analysis industry practices.
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.