This site uses cookies. To find out more, see our Cookies Policy

Manufacturing Quality Engineer (BV) - 12 month FTC in Clare, Ireland at Beckman Coulter Diagnostics

Date Posted: 3/14/2019

Job Snapshot

Job Description

Job ID: BEC014066

About Us

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.
If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com.
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.


Description

Title:              Manufacturing Quality Engineer – BV Program (12 month FTC)        
Level:                         P2        
Reporting To:          Quality Lead –BV Program         
Location:      Beckman Coulter Clare
 
 
RESPONSIBILITIES:
This role has responsibility to support the quality activities associated with the establishment of a manufacturing facility to produce Blood Virus (BV assays)
Typical responsibilities will include but are not limited to the following:
  • Review and approve New Product Development Process Validation documentation/deliverables ensuring compliance to applicable procedures.
  • Co-ordinate the Non-conformance processes (NCs) for New Product Development areas ensuring compliance to Quality and Regulatory Standards. 
  • Support creation, review and approval of Equipment and Manufacturing documentation. Initiate/review/approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices are maintained and comply with company procedures to support Project Deliverables.
  • Ensure Quality project deliverables are achieved within agreed timelines and in compliance with global and local procedures/work instructions.
  • Participate in cross functional teams providing Quality guidance and support to all departments ensuring Good Manufacturing Practices (GMP) and Quality System Regulations are complied with during the receipt/production of product.
  • Analyse and report meaningful quality metrics to ensure on-going improvement programmes are put in place and continually strive for customer satisfaction.
  • Ensuring that internal or external quality issues are effectively prioritised and acted upon in a timely manner, particularly those in the NC/SCAR process.
  • Perform CAPA (corrective and preventive action) activities and document in the Global CAPA system (Smartsolve) if required.
  • Develop strong, positive and beneficial working relationships and effective information flow with other departments and within the Project team and Quality department.
  • Use of Danaher Business System (DBS) tools and techniques to streamline start up processes and ongoing Quality operations e.g. Standard Work, Transactional Processes,  kaizen planning event and lead the implementation of new technologies and innovative solutions into quality activities as appropriate.

Job Requirements



Qualifications

Duties as prescribed by the Quality Lead.
EDUCATION/ EXPERIENCE:
  • Bachelor’s degree in field with 2+ years exp. OR Master’s degree in field with 0-2 years exp
  • A good knowledge of ISO9001/ISO13485, FDA and GMP requirements.
  • Excellent time management and organisation skills.
  • Effective interpersonal and verbal/written communication skills.
  • Strong proof reading skills with emphasise on attention to detail

Diversity & Inclusion
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.