Quality Engineer

Requisition
-Posted - Filtration and Life Sciences - Medical BU - Windsor Locks Plant - Windsor Locks

Work pro-actively to reduce process and product property variation and ensure internal and external specifications are met. To work continuously to improve the quality, functionality and cost effectiveness of existing products. To assist Engineering and Manufacturing with equipment changes and process designs. To handle customer complaint investigations and problem resolution activities. To support, and sometimes lead, product commercialization projects of new product opportunities or modifications to existing products.

Quality Engineering – Maintain the Quality Management System, resolve complaint issues and support continuous improvement.

• Investigate and resolve customer complaints and help determine credit due.
• Handle Medical complaints with a value as high as 1 million dollars.
• Conduct investigations and determine disposition of returned goods. Interacts with Customers to identify the best option for unused, damaged, or defective products.
• Report significant technical issues involving product concerns with customers using call reports and weekly quality highlights.
• Develop and issue specifications, both internally and externally, that are compatible with process capabilities and customer fitness-for-use requirements.
• Provide quality review presentations to senior management of both customers and Ahlstrom.
• Insure compliance with department and all procedures including state, federal and international regulations and standards such as FDA, ISO 9001, ISO 13485 and FSSC
• Participate and lead continuous improvement teams addressing improvement opportunities.
• Provide guidance and assistance to technical service engineers as needed.

• Lead efforts to identify and establish the limits of process capabilities.
• Document / evaluate manufacturing and converting equipment and process parameter trends to improve processes.
• Establish and implement plans to address improvement needs and achieve process improvement for the processes used to manufacture and convert products.
• Establish and implement systems that verify process equipment accuracy and integrity.
• Establish and implement equipment calibration systems in compliance with ISO 9001 standards.
• Identify and address sources of process variability to optimize processing conditions of equipment.
• Identify root causes of processing issues and implement corrective actions.
• Assist Operations in identifying appropriate control moves to address anticipated process and product issues.

New Product Commercialization – Provide leadership to the product commercialization process.

• Lead / support product commercialization projects on assigned equipment and / or for assigned product lines. Projects may include support of complete new product opportunities or improvements on existing products.
• Assist Operations in establishing process parameter settings and operating guidelines for new and established products / equipment.
• Practice disciplined development process by techniques like PFMEA and DFMEA and utilizing the established ASP system.

Product and Process Technical Support – Provide technical expertise on process and product capabilities

• Provide technical support to product lines, customers, and suppliers as needed.
• Work with Engineering and Manufacturing on the design of equipment to ensure desired results are achieved.
• Act as a qualified trainer in area of expertise and provide training as needed.
• Dotted line responsibility over the activities of the Quality Specialist for medical product needs
• Provide guidance and assistance to other technical service engineers as needed.
• CP expert for WLOCKS and the Atlanta Sales office.

Skills Needed:

• Strong oral and written communication skills and interpersonal skills
• Ability to work independently with mininal supervision
• Ability to resolve internal and external technical problems and make decisions regarding quality engineering. proess control and product commercialization issues.
• Experience with FDA required, ISO standards, HACCP, and auditing techniques desireable.