About UsAt 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.
Title : Manufacturing & Supplier Quality Engineer (12 month contract) Level : P2 / P3 (depending on experience) Reporting To : Manufacturing & Supplier Quality Manager Responsibilities / Authority : Typical responsibilities will include but are not limited to the following :
Complete the Supplier Assurance activities within BCII for New Product Development (NPD) ensuring Quality System Regulations are complied with, which will include but are not limited to the following :
Supplier liaison and evaluation including completion of the Supplier Selection Process and review of supplier supplied information via surveys etc.
Auditing of proposed and current suppliers as well as establishment of audit schedule.
Implement receipt / incoming inspection process for the receipt and release of materials as well as supplier specification review and maintenance.
Co-ordinate all BCII Logistics Quality activities related to receiving / goods inwards processes for NPD materials.
Establishment of Ship to Stock programmes, where necessary.
Complete Supplier Change Notifications, as necessary.
Review and approve Process Validation documentation / deliverables ensuring compliance to applicable procedures.
Support creation, review and approval of equipment and manufacturing documentation.
Co-ordinate the Non-conformance processes (NCPR / MRR) for New Product Development areas ensuring compliance to Quality and Regulatory Standards.
Participate in cross functional teams providing Quality guidance and support in the determination of appropriate NCPR / MRR 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.
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.
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 NCPR / MRR / SCAR process.
Support DBS improvement initiatives, utilizing DBS tools including participation in Visual Daily Management, Problem Solving and Kaizen events 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.
Ensure area procedures as well as operational area procedures are updated to ensure compliance. Generate, update, implement and complete associated training for relevant departmental procedures, as required.
Duties as prescribed by the Manufacturing & Supplier Quality Manager.
Education / Experience :
B.Sc in chemistry, biochemistry, engineering or other relevant technical field with at least 3-5 years’ experience in Quality / Supplier 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 OverviewDanaher 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.
Beckman Coulter - Diagnostics