SENIOR QUALITY ASSURANCE SPECIALIST in Mexico City, Mexico at Beckman Coulter Diagnostics

Date Posted: 6/10/2018

Job Snapshot

Job Description

Job ID: BEC010221

About Us

At Beckman Coulter, we are dedicated to advancing and optimizing the laboratory. For more than 80 years, we have been a trusted partner for laboratory professionals, helping to advance scientific research and patient care. We do challenging work on a global scale, and are invested in growing our associates’ careers. We embrace continuous improvement, and are passionate about moving science and healthcare forward.



We have a vital role at Beckman Coulter: our focus on innovation, reliability and efficiency has led us to become the partner of choice for clinical, research and industrial customers all over the world.



Beckman Coulter is a Danaher company, operating in two industries: Diagnostics and Life Sciences. 


Description


Job Description





Provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards. May be responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development. May manage process and product non-conformances in line with company procedures. May conduct quality assurance tests to ensure product specifications are met. May review, investigate, resolve and report on quality discrepancies. May develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards. May monitor, investigate, and report on customer complaints. May obtain the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development. May lead audit and inspection preparation, resolution of audit and inspection findings. May have frequent interaction with other functional areas and operating entities.



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.

Job Requirements



Qualifications

Principal responsibilities
• Ensures that the processes required for the quality management system are established, implemented, and maintained.
• Ensures Quality objectives are met and reports to management on the performance of the quality management system and the need for improvement.
• Participates in the preparation, review, and approval of quality management system procedures and work instructions.
• Provides quality support and guidance to process owners
• Verifies compliance to quality procedures at the site during each stage of the operation Oversees product non-conforming and complaint investigations.
• Assigns and monitors Corrective and Preventive Actions at the site to ensure timely and proper investigation, closure, and effectiveness of the corrective and preventive actions implemented.
• Manages the Stop Ship process.
• Performs final QA review and release of finished product label records.
• Performs QA review, routes and implements change controls on packaging, labeling, and distribution activities.
• Places and maintain QA holds.
• Maintains Quality metrics
• Maintains the Quality Service Provider records.
• Verifies accuracy and completeness of quality records in accordance with the procedures.
• Verifies personnel meet training requirements for their role and that training is documented.
• Assures that there are no significant interruptions to the business due to quality or compliance issues
• Facilitates efficiency improvements for the department.
• Supports the Quality Manager on internal and external audit processes.
• Within area of responsibility, understands and complies with all safety, environmental, and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
• Performs other duties as assigned.
• Performs the internal and external audits according with the regulatory and corporate requirements.

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.



At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.