STAFF QUALITY ENGINEER

JOB SUMMARY

The Staff Quality Engineer will use principles, tools and techniques to develop, and optimize, and support systems and processes that are aligned with the overall Company strategy and mission affecting continuous quality improvement.

DUTIES & RESPONSIBILITIES*

Under (e.g. limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Provide strong leadership in the Quality Operations department to ensure all quality objectives and goals are met and help develop and drive strategic direction of the organization in the areas of quality operations and compliance.
• Support, consult, train and lead quality improvement projects throughout the life cycle of Mentor products, including product design and development, and manufacturing.
• Utilize Quality Engineering tools and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities, support reliability engineering activities, conduct process and systems audits and support specification development.
• Analyzes routine and test data looking for improvement opportunities.  
• Designs and implements experiments (DOE's) for process and product improvement and validation testing.
• Provides statistical support for sampling plan analysis, DOEs, Paretos, ANOVA, and SPC applications, and other statistical applications as required.
• Provide support and drive continuous improvement projects for the site.
• Have knowledge of process validation procedures and provide expertise on developing validation strategies for process improvements, equipment modifications and new equipment introduced into the manufacturing environment.
• Provide quality support for New Product Introductions for the site.
• Evaluate manufacturing quality performance capability and develop criteria to monitor and improve existing processes.
• Serves as technical review for validation activities, i.e. protocols and reports.
• Investigate nonconforming material and the determination of cause, corrective action and recommendation of disposition for the Material Review Board.  
• Apply research and benchmarking activities to create innovative solutions, validate their effectiveness and facilitate their implementation.
• Develop personal performance objectives based upon the facility quality objectives, reporting monthly on progress made against those goals.  
• Prioritizes work to achieve deadlines. 
• Comprehension of the quality System Regulation (21 CFR PART 820), ISO 13485 requirements, EUMDR.
• Serves as the Quality Engineering expert on assigned responsibility areas and has conceptual understanding of all Quality functions and business areas.
• Perform Internal Audits to ensure compliance with QSR, ISO 13485, MDD and Canadian Regulation in accordance with the Internal Audit schedule.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
• Responsible for communicating business related issues or opportunities to next management level
• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION

• A Bachelor’s Degree is required, with a strong preference for engineering or related technical field.
• A minimum of 6 years related manufacturing experience is required.
• Experience in the medical device, pharmaceutical or other highly regulated industry is required.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS *

• Knowledge of ISO1345 and/or cGMP regulations.
• Demonstrated project management and project leadership skills, including managing deliverables.
• Experience in a FDA regulated environment. 
• An ASQ certification (CQE, CQM, CRE or CQA), Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred. 
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc. 
• The ability to perform "hands on" troubleshooting and problem solving is required. Good technical understanding of manufacturing equipment and processes is required.
• Demonstrated project management and project leadership abilities are required.

 
OTHER ADDITIONAL REQUIREMENTS
 

• Ability to periodically interact with associates and processes in a special environment such as a clean room.
• Ability to wear protective garb such as lab or clean room gowns.
• This position will involve periodic entry in a clean room production environment which requires certain preparation and gowning practices.

 
LOCATION & TRAVEL REQUIREMENTS                

• The primary location for the position is at Mentor site in Leiden, Holland.
• Travel is approximately <10% and may include domestic.