Senior Manager, Quality Core Team (1 of 2)

Olympus Corporation of the Americas•Upper Saucon, PA

17h•Remote

About The Position

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.

Requirements

Bachelor of Science, medical, engineering, or scientific discipline required.
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 Advance 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.
Up to 10% domestic/international travel.

Nice To Haves

Design or Process Green I Black Belt is a plus

Responsibilities

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.
Identifis 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.