Use Quality Engineering principles, tools and techniques to develop, optimize, and support systems and processes that are aligned with the overall Company strategy and mission affecting continuous quality improvement;
Duties & responsibilities
Under limited supervision and in accordance with all applicable federal, state, and local laws / regulations and Corporate Johnson & Johnson, procedures and guidelines, this position :
Support the leading of Quality Operations department to ensure all quality objectives and goals are met and help develop and drive strategic direction of the organization;
Capable of developing junior quality engineers and quality technicians in the use of Process Excellence tools and Quality Systems to make data-driven, risk-based decisions that ensure the quality of the product;
Support 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 with expertise and support for sampling plan analysis, DOEs, Pareto, ANOVA, and SPC applications, and other statistical applications as the need arises;
Evaluate manufacturing quality performance capability and develop criteria to monitor and improve existing processes;
Serves as a technical review for validation activities, i.e. protocols and reports;
Investigate nonconforming material and the determination of cause, corrective action and recommendation of disposition Apply research and benchmarking activities to build innovative solutions, validate their efficiency and facilitate their implementation;
Comprehension of the quality System Regulation (21 CFR PART 820), ISO 13485 requirements, MDD, Canadian Regulation and other applicable regulations;
Serves as the Quality Engineering specialist on assigned responsibility areas and has conceptual understanding of all Quality functions and business areas;
Responsible for presenting business related issues or opportunities to next management level;
Experience and education
Bachelor’s degree (B.S.) in engineering, science, mathematics or statistics is required.
Proven knowledge of good manufacturing principles and practices, and procedures;
Medical device or pharmaceutical manufacturing experience is required.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS / LICENSES and AFFILIATIONS .
Proven influential, leadership skills, and able to work on multi-functional teams are required. CQE certification, Six Sigma Blackbelt or Greenbelt certifications are preferred.
Able to communicate optimally within diverse interdepartmental groups.