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Manufacturing Quality Engineer in Clare, Ireland at Beckman Coulter Diagnostics

Date Posted: 11/18/2018

Job Snapshot

Job Description

Job ID: BEC012582

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
 
Level:               P2
                       
Reporting To:               Manufacturing & Supplier Quality Manager
 
 
Responsibilities/Authority:
Typical responsibilities will include but are not limited to the following:
  • Co-ordinate the Manufacturing Non-conformance process (NC) for all BCII Production areas ensuring compliance to Quality and Regulatory Standards.   
  • Participate in cross functional teams providing Quality guidance and support in the determination of appropriate NC root cause analysis and implementation of effective corrective actions.
  • Prepare and co-ordinate the Rework process, ensuring relevant documentation is prepared, reviewed and approved as per company procedures as well as completing Acceptable Quality Level (AQL) inspections prior to product disposition.
  • Execute the Stop Ship process for finished product released to the market, in the Oracle system, ensuring process is compliant to relevant company procedures.
  • Provide guidance and support to all departments ensuring Good Manufacturing Practices (GMP) and Quality System Regulations are complied with during the production of product.
  • Initiate/review/approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices are maintained and comply with company procedures.
  • Provide Quality expertise during investigations, process FMEAs and daily manufacturing issues driving process improvements as well as acting as the Quality Representative on design change projects, if applicable.
  • Review/approve Validation documentation (e.g. protocols, reports) ensuring compliance to applicable procedures.
  • Assist with the QA review & disposition of Batch History Records (BHRs) for all product lines and complete the associated ERP activities ensuring relevant logs and BHRs are maintained.
  • Participate in the BCII Internal Audit Programme as well as representing Manufacturing Quality in both Internal and External audits.
  • Support DBS improvement initiatives, utilizing DBS tools including participation in Visual Daily Management, Problem Solving and Kaizen events in Production as well as own area aimed to ensure quality, safety, productivity, on time delivery and supporting internal customers.
  • Perform CAPA (corrective and preventive action) activities and document in the Global CAPA system if required.
  • Ensure quality issues are communicated to the management team such that they are aware of any potential problems or opportunities. Additionally, generate, analyse and report quality metrics to relevant personnel and to ensure on-going improvement programmes are put in place.
  • Develop strong, positive and beneficial working relationships and effective information flow with other departments and within the Quality department.
  • Generate, update, implement and complete associated training for relevant departmental procedures, as required.
  • Assist in the Supplier Quality process acting as a Supplier Quality representative, if applicable.
  • Duties as prescribed by the Manufacturing & Supplier Quality Manager.

Job Requirements



Qualifications

Education/ Experience:
  • B.Sc in chemistry, biochemistry, engineering or other relevant technical field with at least 3 years’ experience in Quality Assurance in a FDA regulated industry.
  • 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.
                 


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.