Job ID :
US - New York
Job Title: Senior Manager, QA
Requisition ID: 101627BR
Site: Rochester NY
Relocation Assistance Provided
When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
What will you do?
This key leadership position will focus on improving product and process quality for Rochester operations and drive strategic development and culture change for both Rochester operations and the North America region. As the Senior Quality Assurance Manager
Our approach is agile, innovative and collaborative and our teams are genuinely committed to continuous improvement. The results of your contributions are tangible and our belief is "Everyone Owns Quality" .
How will you make an impact?
Set the overall quality strategy for Rochester operations that supports growth and compliance readiness.
Drive quality improvement projects to move the organization from QC to QA mindset.
Lead, maintain and create efficiencies in the Quality Management System to fulfill international quality system requirements (e.g. CFR 820, ISO 13485, and IVDD).
QA management reviews of the Quality System working closely with all staff to ensure that QMS is understood, implemented, maintained and improved.
Cross functional collaboration to drive quality tools including Lean, Six Sigma, TQM principles, business process improvement methods and statistical methods (e.g. design of experiments, statistical process control) across all business units
Manage Corrective and Preventive Action System cross functionally.
Oversee the Internal Audit program, assuring compliance with regulatory standards and participate in any external or customer audits.
Set site wide QA/QC priorities and key objectives, improve the compliance to regulations and overall site Quality System.
Drive Key Quality Business Metrics and Department Metrics.
Act as the site Quality Representative with third party agencies, regulatory agencies and any government agency.
How will you get here?
8+years of experience as Quality Manager in an IVDD, ISO 9001 and ISO 13485 certified Medical Devices manufacturing company.
Host and manage FDA inspections and ISO 13485 and 9001 audits.
Drive CAPA system and SPC programs.
Experience with FMEA and other risk management tools and problem-solving techniques such as PPI, 8D, DMAIC, PPS
Strong, proven leadership, communication, and personnel management skills that inspire and motivate a team. Prior experience with formal goal and objectives setting.
Strong written and verbal communication skills in English, including MS Office (Word and PowerPoint)
Experience working with and managing multiple projects and teams simultaneously
5%-10% travel requirement
Bachelor's Degree in Engineering or Science
Certified Manager of Quality Organizational Excellence ASQ CQM/OE; ASQ lead auditor training 3rd-party training record on ISO 13485 and risk management (ISO 14971)
MDSAP Medical Device Single Audit Program
Lean or Six Sigma improvement systems
Experience in high volume plastics/molding industry.
Apply today! http://jobs.thermofisher.com
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific Inc.