The Senior Quality Engineer (Quality Operation) provides hands-on technical quality engineering support and direction in quality assurance and quality control aspects of the SLC operation to facilitate an environment of compliance and meeting business objectives.
The position requires good knowledge on the disciplines within a medical device QMS and knowledge and understanding of manufacturing, quality control processes and risk management. The incumbent will focus on verification and validations of products and processes and to the proper resolution of nonconformances at any point during the validation process. This position will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to applicable regulations and standards.
The person in this role must have excellent communication and leadership skills, and the ability to plan, multi-task and manage time effectively to ensure activities associated to the role are properly accomplished in a timely manner to avoid regulatory risk. Work is highly independent. May assume a team lead role for the work group.

KNOWLEDGE, SKILLS & QUALIFICATIONS

• Proficiency in quality toolbox including six sigma methodology, lean principles, advanced statistics and other proven quality tools.
• Use of measurement and test equipment.
• Must be a creative problem solver with the ability to troubleshoot a variety of issues.
• Proficient in Microsoft Office (Excel, Word, Database) and statistical analysis programs (Minitab highly preferred).
• Good written and verbal communications skills.
• Strong organizational skills and high level of attention to detail.
• Knowledge of plastic processing, automated and manual assembly of disposable Medical Devices.
• Knowledge of basic Geometric Dimensioning & Tolerancing (GD&T) concepts.
• Must have good mechanical aptitude.
• Demonstrate ability to safely and competently handle returned contaminated medical devices.
• Experience managing personnel (desirable).

EDUCATION AND EXPERIENCE

• Bachelor of Chemical, Biomedical, Mechanical, Industrial, or Manufacturing Engineering (or related field) or STEM
• CQE Certification desirable
• Experience working in a team environment successfully bringing medical device products through an FDA regulatory pathway and compliance with internal Quality Management System (QMS)
• Experience in technical writing of documents in regulated industries.
• Strong knowledge of medical device validation processes, risk management, and regulatory requirements (FDA 21 CFR Part 820, ISO 14971, ISO 13485).
• 7+ years’ experience

MINIMUM QUALIFICATIONS

• Must be 18 years of age

TRAVEL REQUIREMENTS

• Typically requires travel less than 15% of the time

PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT

• Work is performed in a safe environment.
• While performing the duties of this job, the employee is regularly required to work inside a clean room/controlled area environment.
• This job operates in a professional office environment and routinely uses standard office equipment. May perform duties in a laboratory environment.
• Must be able to occasionally move objects up to 25 lbs.

• Partner with Engineering, Maintenance, Production, Quality Operation and other functions to drive prompt resolution of quality problems for product and processes and to drive the highest quality results.
• Implement quality engineering tools in the operation to drive methodical and process-based approaches to product and process improvements.
• Develop and execute validation protocols (IQ/OQ/PQ) for manufacturing equipment, processes, and software systems.
• Develop and execute Test Method Validations for manufacturing processes and laboratory equipment, as needed.
• Develop/update sampling plans by applying attribute, variable, and sequential sampling methods.
• Develop/update local procedures, Test Methods, and standards.
• Manages testing outlined in protocols and test methods.
• Manages/develops validation studies on equipment, automation software & processes.
• Initiate, manage and support of ship holds, product holds, and potential product escapes associated to nonconformances.
• Have the ability to methodically process and investigate in a high-paced, efficient and accurate manner.
• Proactively escalate significant quality issues observed while running the processes under responsibility and propose solutions.
• Analyzes, plans, organizes and completes projects of a very complex nature. Develops scope and provides creative solutions. Plans, organizes and conducts technical projects.
• Be proficient in and make continuous strides towards optimization of inspection methods and sampling.
• Improve Quality System through internal audits and compliance audits.
• Delivers communications tailored to the needs of the receiver (managers, peers, project stakeholders) with appropriate frequency to promote cross-functional collaboration. Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus.
• Coach and mentor others in quality topics and activities. May provide input on performance evaluations to area manager.
• Working effectively in a team environment with shifting priorities and time sensitive requirements.
• Performs other functions as necessary or as assigned.
• Work on special projects as they arise
• Ability to train/transfer knowledge to others.