Senior Quality Engineer

Pall Corporation is a Fortune 1000 materials science and engineering company with the broadest filtration, separation and purification capabilities in the world. Our process and product enabling technologies help our customers make good products better, safer and even possible. We provide innovative products to customers in health care, biotechnology, pharmaceutical, semiconductor, and municipal drinking water, aerospace and industrial manufacturing markets. Headquartered in NY, Pall has operations in every major country. 

Embedded in PALL Corporation, PALL’s Single Use Technology business unit is a new, innovative, growing business unit of the company. For the upcoming year, this business unit is expected to have a double digit growth. We develop cutting edge technologies for the biopharm/biotech industries, to offer our customers a cost-effective single use integrated process solution, supported by comprehensive technical services. The Single Use product range entails fluid storage, filtration, inter-connectors, mixing, storage, separation, and bioreactor technologies.

Our QUALITY DEPARTMENT in Hoegaarden is looking forward to welcoming an 

Senior Quality Engineer
 

The Senior Quality Engineer is leading quality investigation, keeping oversight of quality complaints (internal and external) and managing the metrics and KPI (Q OBEYA) related to this.
The senior quality engineer is maintaining 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.
The Senior Quality Engineer will be closely engaged in R&D projects towards introduction of new products as quality lead.

Your responsibilities:

• 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;
• 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 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.

Your profile:

• 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;
• Fluent in Dutch and English.

Our offer:

• Working in an international & innovative environment in a traffic-free region (Hoegaarden) with various career opportunities
• Being part of and participate in early stage technology improvements and product creation
• A fix contract of unlimited duration with market competitive salary package
• On top of the financial aspect you will join a culture of training opportunities, autonomy in work & recognition of responsibilities