Senior Quality Specialist
About The Position
As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Requirements
- Requires a bachelor's degree in an Engineering or relevant Scientific discipline.
- A minimum of 5 years of relevant experience or a combination of equivalent education and relevant experience.
- Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, IVDD, EU IVDR, Canadian MDR, Japan PMDA as well as ANVISA and TGA requirements.
- In-depth understanding of the application of quality systems to the medical device industry.
- Experience supporting internal and/or external audits.
- Proficient with electronic document and change management systems.
- Exceptional attention to detail & strong project management skills.
- Excellent technical writing skills and communication skills at all levels both written and verbal.
- Ability to set and deliver to specific goals and targets.
- Ability to perform multiple tasks and prioritize workload.
- Effective analytical, technical, and problem-solving skills.
- Effective meeting and presentation skills.
- Effectively manage conflict.
- Ability to work in or direct teams to obtain results.
- Self-motivated /directed.
Responsibilities
- Develops and implements QMS integration plans.
- Coordinates the execution of QMS integration plans in collaboration with stakeholders and in accordance with business priorities.
- Drives execution of integration related activities, including but not limited to labeling changes, procedure updates, training updates, etc.
- Assists with NB, Corporate and other regulatory, external, and internal audit readiness.
- Assist with execution of internal audits.
- Applies quality and/or standard-setting body requirements to develop solutions, control and/or maintain technical documents and/or Quality Systems.
- Trains, develops, and provides technical guidance to other associates.
- Actively participate in quality guidance and helps project & quality network teams for process improvement, standardization initiatives, and continuous improvement activities.
- Completes projects/other duties as assigned.
Benefits
- comprehensive Total Rewards program
- reward and recognition opportunities that promote a performance-based culture
- competitive package of compensation and benefits programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
