Quality Specialist Sr na Ashland

Are you the kind of person that is always thinking, sketching, seeking, and adjusting? Who needs to understand how things work and then figure out how they can work better? Are you a passionate, tenacious, solver who loves to work with others who share your drive? Are you positive, constructive, and ingenious?

Are you always solving?

Then we’d like to meet you and bet you’d like to meet us.

Ashland has an exciting opportunity for a Quality Compliance Specialist to join our Diagnostic Films business at our Columbus, Ohio location. This is a very visible, significant role within the Company and the quality and regulatory function. This position will report to the Manager of Quality Columbus site.

This position would support the compliance, maintenance and continual improvement of the facility’s Diagnostic Films quality management and regulatory compliance systems while safeguarding alignment with applicable ISO standards (ISO 13485), regulatory requirements, business objectives, and customer needs.

The responsibilities of the position include, but are not limited to, the following:

• Maintain the facility QMS in alignment with the global QMS.
• Maintain facility and operational compliance with relevant global medical device regulations, including but not limited to FDA 21 CFR 820 and EU MDR
• Manage the applicable site establishment registrations and listings
• Lead medical device design control activities per 21 CFR 830 requirements
• Lead global regulatory submissions, review of labelling and marketing materials for Ashland’s medical devices
• Develop relevant Quality/Regulatory SOPs as necessary
• Conduct batch record review and release conforming product
• Lead investigations for quality incidents and out of specification production
• Lead the internal audit program.
• Provide direct customer support responding to customer requests and complaints.
• Perform validation of quality processes through establishment of product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
• Developing quality assurance plans by identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and inventories.
• Consolidate quality KPIs, prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
• Provide valuable problem solving, project and change management abilities to lead or participate in continuous improvements in quality.

In order to be qualified for this role, you must possess the following:

• B.S. Degree in Chemistry or Chemical Engineering or a related discipline.
• 3-5 years of experience within the quality or regulatory function in a manufacturing facility that produces medical devices.
• Experience with medical device design controls and global regulatory submissions (including but not limited to 510(k) and CE mark)
• Experience with GMP internal and external quality audits.
• Experience working within and complying with ISO 13485, 21 CFR 820, and EU MDR

The following skill sets are preferred by the business unit:

• Regulatory Expertise – Demonstrated knowledge of medical device design controls requirements, submissions, registrations, product/process change evaluation, review of labeling and promotional materials, and interaction with regulatory authorities would be a plus.
• Project Management Abilities – Able to provide problem-solving and project management abilities to lead or participate in continuous improvements in product quality, GMP, and regulatory compliance, and the Quality Management System.
• Manufacturing operations experience preferred.
• Communication Skills – Able to clearly and effectively communicate verbal and written information appropriately to an audience. Able to deliver information in a formalized and group setting. Able to translate complicated and/or technical information in a simplified format that can be easily understood.
• Problem-Solving Skills – Able to determine causal factors and develop corrective and preventive actions while anticipating challenges that might occur.
• Computer Skills – Good knowledge of Office tools (Microsoft Office Word, Excel, and PowerPoint). Ability to interpret and analyze statistical data. SAP experience a plus.
• Minimal Travel Required