Quality Assurance Specialist III in Brea, California at HemoCue America

Date Posted: 10/12/2018

Job Snapshot

Job Description

Job ID: HEM000557

About Us

HemoCue, acquired by Radiometer Medical ApS in April 2013, is a global leader in point-of-care testing. We are convinced that HemoCue point-of-care testing contributes to better healthcare, by providing the data you need, when and where you need it, to make accurate healthcare decisions quickly. In 1982, HemoCue AB introduced the first accurate, near-patient hemoglobin test. The company also sells point-of-care tests for glucose, urine albumin, HbA1c, total and differential white blood cell count which are being used in over 130 countries. Further information, visit http://www.hemocue.com

Radiometer - Make an impact on life. The difference between life and death can be just a few minutes. Radiometer’s diagnostic equipment is of crucial importance to doctors all over the world in their effort to diagnose critically ill patients quickly and accurately. From biotech and software specialists to financial controllers and engineers, all 2500 colleagues are committed and dedicated in their effort to make an impact on the life of others with our high-quality solutions. Radiometer’s leading position in the market has been secured over the last 50 years. Together we continue to raise the bar in acute care and constantly develop in new areas. Radiometer has an annual turnover of more than DKK 3 billion and is owned by US-based Danaher Corporation.

Radiometer 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.



Description

  • Overall management of QA/RA services and functions to support 100% compliance with governmental and regulatory organizations, including but not limited to FDA, ISO and UL
  • Functions as Lead Auditor to schedule, plan, perform, and document internal audits 
  • Ensures that all internal audit findings are closed in a timely manner with effective corrective action by assisting observation owners on investigations, action plans, and/or verification plans.
  • Functions as Lead Auditor in collaboration with HemoCue AB to plan, perform and document supplier audits. Ensure that supplier audits are closed in a timely manner.
  • Oversees NCR, CAPA, SCAR and XR processes, including document investigations, action implementation and effectiveness verification on time and according to procedure
  • Acts as Management Representative for HemoCue America, as defined by the Quality System Regulation as defined by the Quality System Regulation. Lead semi-annual Management Review meetings with the Leadership Team
  • Oversees Literature Review Processes. Must be trained in and use the procedure for establishment, dissemination, review and approval and handling of all product marketing, advertising, promotional, scientific and sales materials (MAPSS) to ensure it complies with all applicable laws and regulations.
  • Oversees Business Continuity Plan, assuring plan is reviewed on an annual basis
  • Oversees EHS
  • Knowledgeable in all regulatory requirements for USEPA, OSHA, federal, state, local jurisdictions
  • Ability to train  staff on all applicable EHS requirements for the business
  • Be a resource to associates as it relates to EHS issues, questions and support. Collects, reports and posts, OSHA related injury illness data to clients and internal management
  • Manage the maintenance and implementation of safety programs, compliance plans, and initiatives
  • Conduct routine safety observations to ensure compliance with regulatory agencies, company environmental, health, and safety policies, procedures and practices. 


Job Requirements



Qualifications

  • Position Specific Competencies / Experience
  • At least 5 years Quality Assurance or 5 years Quality Systems experience
  • At least 2 years working within a Medical Device/Clinical Laboratory environment
  • Knowledge of FDA regulations, guidance and policy regarding medical devices
  • Experience in assessing quality functions, identifying gaps, writing procedures, and implementing new systems to assure compliance with company and regulatory requirements
  • Thorough knowledge of Management Controls, CAPA, Document Controls, Material Controls and Equipment/Facility Controls.  Specific experience in design and implementation of Document Control and CAPA systems in the medical device industry
  • Demonstrated ability to manage and coach team to success
  • Ability to design training programs involving Quality System Regulation issues and conduct training for all levels of personnel
  • Utilize Danaher Business Systems (DBS) tools on a regular basis to drive continuous improvement
  • Knowledge of and experience in OSHA/safety and EHS requirements
  • Strong Planning and Time Management
  • Highly developed communication skills and ability to work effectively in matrix environment
  • Education: Bachelors’ in Business or Scientific discipline is required
  • Language: English
  • Strong capabilities with Microsoft Office products, with advanced Excel skills.
  • Travel (required estimated % of time): 20%


At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.



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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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.