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Sr Manager, Quality
2 weeks ago
Other
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Key Duties and Responsibilities
Support and provide expertise to the Quality Management System (QMS) and Quality department to successfully meet or exceed goals and targets
Collaborate with the various functions to ensure the quality management system is comprehensive, incorporates standard processes, and is consistent with the strategic plan
Product Development responsibilities including design controls, risk management, document control and record management, and supplier management
Manufacturing responsibilities including master record, training, process controls, labeling, change control, and CAPA
Responsible for monitoring and measurement including validations, calibrations, customer feedback and complaints, internal audits
Responsible for all site quality metrics and reporting for monthly and quarterly business reviews - e.g., Product Complaint rates, Cost of Poor Quality, CAPA, etc.
Support and provide quality expertise to the business process transfer activities - e.g., process implementation/validation
Hire and retain a diverse, highly qualified staff and provides ongoing performance feedback. Set goals which align to department plans and lead the execution of goals through coaching and mentoring
Ensure continuous improvement through the Practical Process Improvement (PPI)
Install and maintain a quality culture - Right First Time
Keys to Success:
Education:
- Bachelor of Science Degree in - Life Sciences, Engineering or related science/engineering degree preferred
- 10+ years of professional quality experience - quality leadership experience preferred
- Understanding of the Life Sciences and IVD/Medical Devices industries and required compliance regulations for Genetic Sciences products and processes
- Solid understanding and experience with ISO 9001 and ISO 13485 standards
- Experience in MDSAP, IVD/IVDR, 510K and GxP requirements preferred
- Ability to travel domestically and internationally - up to 15%
- Expert knowledge and experience implementing the following:
- Design and Process FMEA's (Failure Mode Effects Analysis)
- CAPA (Corrective and Preventive Actions) process
- NPI (New Product Introduction) process - Design Transfer, V&V
- Complaints Handling process
- Change Control process
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