BD is looking to solve quality engineering related R&D activities from research through product launch to ensure that quality engineering principles are applied to new product development and sustaining engineering projects.
Requirements
- Demonstrates strong knowledge of quality engineering policies, principles and best practices
- Understanding of regulatory and international standards requirements including 21 CFR 210, 211, ISO 13485, ISO 14971
- Applies comprehensive knowledge of Design Transfer activities with the Operations environment
- Knowledge of product development processes and application of Design Controls
- Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)
- Proficiency in Excel, Word, and other desktop/general business systems
- Quality Engineering Certification (ASQ) or equivalent (preferred)
Responsibilities
- Responsible for being the core team Ops Quality representative for design control projects – new product development as well as sustaining efforts.
- Lead Quality efforts for successful Design Transfer of ongoing changes to commercialized products and for new products coming into manufacturing for the first time
- Provide clarification and guidance to teams on overall quality system with emphasis in design controls.
- Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release.
- Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.).
- Identifies Product Quality improvements directly linked to better outcomes in the customer experience and compliance position (Nonconformances, early failures, failures at install, etc.) and act as the champion to push projects forward.
- Ownership of data analysis on ISC/Ops Quality owned Quality metrics (NCs, Failures at Installation (FAI), Out of Box Failures (OOB), etc.. to identify improvement opportunities.
Other
- Bachelor’s degree in Engineering (or relevant STEM field)
- Minimum 6 years’ experience with emphasis on Design Transfer, Quality Engineering and Design Control
- Attentiveness to details with strong organizational skills
- Ability to work proactively and independently
- Ability to multi-task and efficient in time management
- Excellent verbal communication and interpersonal skills with the ability to work in a team environment
