Quality Manager

Ashland Inc. • Columbus, OH

19h • Hybrid

About The Position

Ashland has an exciting opportunity for a Quality Manager to join our ISP Chemicals business at our Columbus, OH location. This is a very visible, significant role within the Company and the Quality function. This position will report to Quality Systems Manager. The responsibilities of the position include, but are not limited to, the following: The Quality Manager supports the Quality Systems Manager in verification, enhancement, and improvement of the processes and systems associated with the design, manufacturing, testing, and release of final medical device products at the facility. Assists in maintaining production processes to ensure accuracy, standardization, and compliance to specified quality systems. Supports quality control measures by developing and improving procedures. Lead supplier quality activities, continuous improvement initiatives, and facility compliance to quality system regulations. Lead customer and regulatory audits, internal audits, supplier audits, and investigating product failures and non-conformances. Travel Responsibilities – 20-25% of the time Actively contribute to the organizational goals by taking initiative, executing on goals and focusing on performance and safety Improve the organization capacity and capabilities through building collaborative relationships, optimizing diverse talent and utilizing positive communications and influence with others What This Role Is Not: Not a management position – while you will collaborate with other team members, this is an individual contributor role with no direct reports Not an office-based role – You will spend your time supporting manufacturing and R&D activities. Not an entry level position – we need a candidate to hit the ground running with solid experience and a background to prove it

Requirements

• Bachelor’s degree in chemistry, chemical engineering, or similar related scientific fields or equivalent relevant industry experience
• 5+ years’ experience in a medical device manufacturing environment
• Knowledge and experience with quality systems associated with manufacturing of medical devices (ISO 13485, 21 CFR 820, EU MDR).
• Experience with medical device design controls and global regulatory submissions (including but not limited to 510(k) and CE mark)
• Experience with medical device internal and external quality audits.
• Demonstrated responsible and ethical behavior at all times
• The ability to help the company drive greater value through understanding the business, making complex decisions and creating the new and different

Nice To Haves

• 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.
• 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.
• 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.

Responsibilities

• Supports the Quality Systems Manager in verification, enhancement, and improvement of the processes and systems associated with the design, manufacturing, testing, and release of final medical device products at the facility.
• Assists in maintaining production processes to ensure accuracy, standardization, and compliance to specified quality systems.
• Supports quality control measures by developing and improving procedures.
• Lead supplier quality activities, continuous improvement initiatives, and facility compliance to quality system regulations.
• Lead customer and regulatory audits, internal audits, supplier audits, and investigating product failures and non-conformances.
• Actively contribute to the organizational goals by taking initiative, executing on goals and focusing on performance and safety.
• Improve the organization capacity and capabilities through building collaborative relationships, optimizing diverse talent and utilizing positive communications and influence with others.

Benefits

• Team recognition rewards, sponsored lunches and monetary incentives based on performance
• Comprehensive Benefit package, Medical, Dental and Vision starting on Day 1 for you AND your family
• 401(k) plan with company match
• Referral bonus plan
• Flexible office location – Remote/Hybrid

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level