Senior Quality Assurance Scientist – Complaint Handling - Miami, FL | Biospace
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Senior Quality Assurance Scientist – Complaint Handling

Beckman Coulter, Inc.

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Location:
Miami, FL
Posted Date:
9/14/2017
Position Type:
Full time
Job Code:
BEC007154
Salary:
Commensurate w/ exp
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

The Senior Quality Assurance Scientist will participate in complaint handling activities for the purpose of ensuring compliance with US and international regulatory compliance and medical device reporting requirements, as well as improving the customer experience.  These activities will include receiving, documenting, evaluating, and managing all complaints and other Customer Feedback (CF).

Responsibilities:
Receive and process complaints escalated from internal and external customers related to products manufactured and or distributed and serviced by the company in a manner consistent with all laws and regulations for medical devices.
Apply departmental procedures to the evaluation of complaint information for acceptable content and supporting data.
Generate and analyze customer feedback (CF) data to improve product reliability and performance for our customers.
Assess complaint information for determination of adverse event reporting and/or vigilance reporting.
Contact customer with findings of CF/complaint investigation as needed, and document outcome of the customer call or write a customer letter.
Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans.
Independently and collaboratively evaluate information, reports, and data and provide recommendations for process improvements.
Verify accuracy and completeness of pertinent records and documentation.
Possess understanding of risk management concepts and is capable of assessing product risks across unit of work.
Identify critical product issues and escalate through the quality system for Field Action, Corrective and Preventive Action (CAPA), Supplier Corrective Action, and/or Stop Shipment activities.
Provide input to project teams on project specific processes and deliverables. Ensure completion of key deliverables.
Perform queries as necessary to respond to regulatory requests/inquiries.
Upon request, performs specific data queries, prepares complaint reports, and communicates the results.
Other duties and projects as may be assigned.

Requirements

Bachelor’s degree with 5+ years in Science or Engineering discipline, or relevant years of Quality/Regulatory Affairs experience
Master’s degree with 3+ years in Science or Engineering discipline, or relevant years of Quality/Regulatory Affairs experience
Doctoral degree with 1 year in Science or Engineering discipline, or relevant years of Quality/Regulatory Affairs experience
Medical Technologist /Clinical Laboratory background preferred
EXPERIENCE DESIRED:
Ability to drive results, foster teamwork, handle pressure, and provide feedback
Knowledge of domestic and international quality systems and other standards such as FDA, QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulations.
Experience participating on cross functional teams.
Hematology product knowledge
PERSONAL SKILLS / ATTRIBUTES:
Able to make judgment calls using combination of knowledge of regulations, knowledge of technology, critical thinking, and interpretation of intent of the regulations.
Able to apply extensive technical expertise and has full knowledge of other related disciplines.
Ability to perform detail-oriented work with a high degree of accuracy.
Proven ability to work cross-functionally in a team based environment.
Proficient in MS Office Suite of products.
Willingness to be flexible and adaptable to changing priorities.
Excellent oral and written communication skills.
Effective analytical and problem solving skills.
Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.