Danaher Corporation Senior Quality Engineer in Medemblik, Netherlands
Danaher Company Description
Pall Corporation is a global leader in high-tech filtration, separation, and purification, serving the diverse needs of customers across the broad spectrum of life sciences and industry. Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biotech drugs, vaccines, cell therapies and classic pharmaceuticals. Pall offers advanced medical technologies, which are often a patient’s last line of defense from dangerous pathogens. Pall’s food and beverage products provide critical protection from contaminants during various manufacturing steps. Pall Industrial serves a diverse range of customers in the microelectronics, aerospace, fuels, petrochemical, chemical, automotive, and power generation industries. Pall is a key supplier to the innovative and demanding semiconductor and consumer electronics industries, and provides filtration products used in critical applications on commercial and military aerospace vehicles. Pall products are key to the reliability of industrial equipment. Pall’s engineered solutions help municipal and industrial customers address mounting water quality, scarcity and demand issues, and help energy companies maximize production and develop commercially successful next generation fuels. Headquartered in Port Washington, New York, Pall has offices and plants throughout the world. To learn more about Pall, please visithttps://www.pall.com/en/about-pall.html.
Goal of the position:
The Senior Quality Engineer is leading quality investigation, keeping oversight of quality complaints (internal and external) and managing the metrics and KPI related to this. He / She maintains the overview of the validated state of products, processes, methods and equipment. He / She is handling deviations of any kind. The Senior Quality Engineer is the Quality Lead in plant wide projects. He / She is closely engaged in R&D projects towards introduction of new products as quality lead.
- Support/lead ME/PE to implement/maintain, as a team member, Process flow charts, Process Control Plans, Process FMEA, validations;
- Support transfer from NPI to high volume manufacturing and develop quality control plans;
- Responsible for issuing or reviewing and approving validation documents related to gamma irradiation and product sterility claims;
- Coordinate validation activities & development of analysis methods with laboratory contractors;
- Ensure supplier qualification (during the NPD process): prepare, perform and follow up on supplier audits;
- Manage POR processes; assure root cause analysis and effectively implement robust CAPA. Follow-up and verification of CAPAs to assure no recurrence. Facilitate the closures of NCRs in a timely manner;
- Manage and maintain overview of all external customer complaints (Daily management in OBEYA PPM reduction);
- Manage CAPA processes; assure root cause analysis and effectively implement robust CAPA in a timely manner. Follow-up and verification of CAPAs to assure no recurrence. Adhere to corporate escalation and reporting guidelines;
- Implement continuous improvement practices, including appropriate kaizen events on relevant Quality processes. Support Shin Kaizen events and use Lean manufacturing principles, as and when required. Roll out CDT&R, VOP, DRS, PSP, FMEA- utilizes DBS to drive continuous improvements;
- Provide Manufacturing Quality Trend Charts/Analysis and suggest/implement improvements based on the trends;
- Support Supplier Quality Engineer for driving improvements for Supplier related issues (SCARs), work closely with Purchasing / SS to select/maintain/drop Suppliers list based on their performance;
- Support QMS to meet ISO 9001 / ISO 13485 requirements; identify and implement/maintain specific standards to QMS;
- Perform Internal Audits per the annual audit schedule, prepare report, follow-up and verification of completion of actions initiated from audit(s);
- Works closely with Sales, R&D, and Manufacturing to optimize the company's products and relationships with our customers including technical presentations at Customer sites;
- Support responses to customer questionnaires, certification requests and surveys; prepare and maintain/update standard responses/data for use by Customer Service;
- Support customer audits and be the quality contact for customer and supplier questions regarding sterility, POR, SCAR, validation and deviation;
- Implement, maintain and monitor change control and customer notification procedures;
- Accountable/Responsible for maintaining Quality KPI's; drive improvement(s) to continually improve the goals/KPIs.
- Is the go-to-point when non-routine quality issues occur.
Education, Skills & Competencies:
- Master in a scientific field, preferable in Lifesciences (bio, biomedical, chemical, pharma, …);
- 5-10 years of relevant experience;
- Uses analytical mind and data analysis to creatively and pragmatically solve problems, comes up with solutions;
- Gives guidance to more junior team members, shares experiences;
- Understands and has knowledge of the multiple functions within the quality team (can work cross functional);
- Can make straight forward decisions based upon data analysis, own (risk) assessment, precedents and procedures;
- Can work independent as a quality lead within a team of R&D and product engineers to support successful implementation of new projects and products;
- Proficiency in Excel (statistical), ERP system and LIMS are a plus;
- Six Sigma;
- Ability to travel 5-15% (domestic and international);
- Fluent in Dutch and English;
- Pro-actively makes recommendations for future improvements;
- Is aware of and appropriately uses DBS tools (e.g. PSP, FMEA,…);
- Is engaged and taking initiatives towards continuous improvement;
- Able to work in team and influence others.
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.
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Western Europe-Netherlands-NH-Medemblik
Req ID: LIF004125