- Right First Time.
- Design Transfer, V&V, Complaints Handling process and Change Control processExperience working and providing customer support, investigations, and relationship managementExperience supporting organizational change effortsKnowledge, Skills, and Abilities:Understanding of the Life Sciences and IVD/Medical Devices industries and required compliance regulations for Cell Culture and Supplement products and processes preferred.
- Normally receives little instruction on day to day work, general instructions on new assignments.
- Integrity, Intensity, Innovation and Involvement working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
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Sr Quality Manager - Miami, United States - Thermo Fisher Scientific
Description
Job DescriptionAs 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.
How will you make an impact?The Sr Quality Manager is a leadership position responsible for implementing and improving Site Quality Management System and Quality Assurance structure to cover various internal functions, build scale, and most relevantly, better serve our customers.
What will you do?Support and provide expertise to the Quality Management System (QMS) and Quality department to optimally 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
How will you get here?Education:
Minimum required education:
Bachelor's Degree: Life Sciences, Engineering or related science/engineering degree preferredExperience:10+ years of professional quality experience required5+ years of people leadership experience in quality operations environmentQuality site leadership experienced preferredProven understanding and experience with ISO 9001 and ISO 13485 standardsExperienced knowledge and implement the following: Design and Process FMEA's (Failure Mode Effects Analysis), CAPA (Corrective and Preventive Actions) process, NPI (New Product Introduction) process
Must possess the presentation skills and integrity to project a professional image, both internally and externallyStrong interpersonal, verbal and written communications skills are important.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of valuesApply today http:
//jobs.thermofisher.comThermo 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.
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