Sr Global Quality Assurance Scientist - CAPA Process in Brea, California at Beckman Coulter Diagnostics

Date Posted: 6/22/2018

Job Snapshot

Job Description

Job ID: BEC010852

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

The Senior Global Quality Assurance Scientist is accountable and responsible for supporting the company’s global quality system Corrective Action and Preventive Action (CAPA) process. The position supports the CAPA Global Process Owner and is responsible for coordinating the development, governance and integration of these processes into our global Quality Management System (QMS). This position is accountable for initiating and supporting quality systems activities in all aspects of the business, including identification and implementation of continuous process improvement activities. 


The qualified candidate will be able to demonstrate leadership capability and skills necessary to lead a global team through assessment of existing CAPA gaps, creation of interim and future state process solutions and monitor implementation for compliance to applicable FDA and global regulation.

Principal Responsibilities:


  • Oversee coordination of the Global CAPA Review Board and function as the Global Process Owner delegate for the Company’s global Quality CAPA process

  • Coordinates and oversees Quality activities directed towards assessing site/business unit compliance to all appropriate standards, specifications, contractual requirements, and government regulations, both internally and externally

  • Build working relationships with Business Unit Quality System Compliance team, Development, Supply Chain, Program Management, Commercial Operations, Regulatory Affairs, Chief Medical Officer, etc. to ensure process solutions are compliant, efficient, and adaptable to business units, sites and functions throughout the world

  • Administrative duties include but are not limited to the monitoring of information relative to problem statements, root cause analysis, corrections, corrective and preventative actions, tracking of time lines, and establishing CAPA files

  • Serve as the coordinator of the CAPA meetings

  • Generate, analyze and coordinate Quality System Metrics for business level review, as needed

  • Maintains oversight, tracking, and escalation for Quality System Compliance, takes action to ensure process are maintained per company policies and industry standards

  • Provide continuous process improvement and consultation and support of the Quality System Compliance Processes as required, at global sites

  • May function as global representative for company Quality System Compliance process during Internal, Danaher Audits and assists in the preparation and submission of audit responses and requests for information to FDA, Notified Body and other Regulatory Bodies

  • Implements/modifies quality systems to address changing Regulations or industry standard, providing regulatory interpretation and guidance where required

  • Maintaining policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and European Union Medical Device Directives (MDD) as well as all other applicable global regulatory requirements

  • Maintains up-to-date knowledge and ensures proactive compliance to FDA & EU regulations and other applicable worldwide standards and requirements specifically as related to medical device industry and quality system regulations

  • Development and implementation of tactical plans to meet Company and Corporate objectives, and supporting the development and implementation of policies to ensure compliance with applicable US Federal and local compliance regulations

  • Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively

  • Utilize Danaher Business System (DBS) tools to drive compliance and effective processes

Job Requirements



Qualifications



  • A Bachelor’s degree with 5+ years of experience or Master’s degree with 3+ years of experience, preferably in areas of life sciences, engineering, or quality assurance


  • Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)


  • American Society for Quality certification is preferred


  • Certified Practitioner in a DBS tool is not required but would be a plus.

Experience Desired



  • Strong problem solving skills, as evidenced by comfort using the Problem Solving Process (PSP) and Visual and Daily Management (DM)

  • Strong knowledge of Quality, Regulatory compliance, and operations systems and processes, including GMP and QSR requirements for medical devices. (ISO13485, FDA’s QSRs, EU’s MDD, Canadian Regulations) is required

  • Proficiency in the Microsoft Office suite of products is required, Mastery in Outlook and Excel would be a plus

  • Demonstrates knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations

  • Possess a broad knowledge of surrounding areas including Regulatory & Compliance Development


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.