Senior Quality Engineer

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.

WE ARE LOOKING FOR:

• 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.

DO YOU HAVE…?

• 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).

Preferred:

• 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.

If the answer is YES, don’t delay Apply Today!