[Hiring] Senior Manager, Quality Core Team @Olympus Corporation of the Americas

Role Description

This role represents the Voice of Quality (design quality, reliability, ops/mfg. quality, supplier quality, quality systems, post market quality, etc.) on cross-functional new product development (NPD) project core teams. This role is responsible and empowered to establish the quality and reliability strategy and DRM metrics for the project. This position has responsibility for influencing product quality and reliability outcomes across NPD and serves as the final quality authority on the project team.

Job Duties

• Functional expertise to NPD projects and represent voice of quality on cross functional project teams
• Project management for the extended Quality team of one or more NPD projects
• Project management of initiatives to improve the quality and consistency of quality business processes and work product
• Applies the requirements of the Quality System to processes, products or services
• Supports validation and verification strategy for new and existing products and processes as assigned
• Develops and drives measurable Quality Improvements relating to products processes and services
• Develops Quality functional strategies, plans and schedules to meet project goals and manage risks
• Manages Quality escalations and drive resolutions with Core Team by working cross-functionally to ensure issue ownership, action and appropriate communication
• Drives critical thinking, functional excellence, lessons-learned and business and quality management system improvement
• Represents Voice of Quality for assigned project(s)
• Ensures design and quality requirements are effectively defined and implemented
• Proactively drives and champions strategic quality, reliability and safety initiatives such as DFSS activities, DFR, DFM, complaint reduction, risk management, etc.
• Identifies quality risks and implements risk burn down strategies
• Drives/leads root cause analysis and closed-loop corrective/preventive action
• Ensures an effective transfer to global post-market quality functions
• Coaches & supports project team members on compliance with quality system requirements
• Provides quality functional support for key project activities and deliverables including design history file (DHF), device master record (DMR), regulatory submissions, issue resolution, etc.

Qualifications

• Bachelor of Science, medical, engineering, or scientific discipline required. Design or Process Green I Black Belt is a plus
• Minimum of 8 years of experience within a drug/device manufacturer/distributor with a focus on QSR compliance and quality assurance
• Minimum of 5 years’ experience supporting new product development with 3+ years of experience as a Quality Core Team member
• Knowledge of basic mechanical, electric, software, optical, or biological engineering
• Knowledge of basic medical device regulations and standards (e.g. 21CFR part 820, ISO 13485, ISO 14971)
• Working knowledge of problem-Solving Tools (i.e. Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PDCA, Pareto Analysis, etc.)
• Working knowledge of Quality Tools (i.e. Quality Planning, Quality Costs and Assessment, Basic Statistics, Advanced Statistical Techniques, Technical Writing, Metrology & Calibration, Inspection and Testing, Sampling Principles, and Six Sigma, etc.)
• Knowledgeable about extended Quality team functions throughout the product development process
• Collaborative across functional boundaries in matrixed organizational structure
• Proven track record in New Product Development delivering on robust, customer and patient focused product quality
• Strong technical skills related to product quality including VOE translation to Design Inputs and Outputs, Design Characterization, Verification / Validation, Test Method Validation, and Statistical techniques
• Strong working knowledge of FDA QSR's, MDSAP, ISO 13485, Design Controls, and Risk Management practice
• Good verbal and written communication skills demonstrated by ability to generate technical reports and ability to make presentations to middle and upper management
• Proven Project Management skills
• Proficient in the use of Information Technology and applications
• English ability: TOEIC 600 plus or equivalent
• Strong collaboration skills and the ability to work across functions and geographies

Requirements

• This role is based in Japan with up to 10% domestic/international travel

Benefits

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive medical, dental, vision coverage effective on start date
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance*
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center**