Quality Manager

ISP Chemicals LLC

Quality Manager

 

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 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

 

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

 

• 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

 

 

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.
• 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.

 

Perks of working at Ashland:

 

• 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 – get a job with us and get paid to refer your friends
• Supporting work/life balance, we offer Flexible office location – Remote/Hybrid

In more than 100 countries, the people of Ashland LLC. (NYSE: ASH) provide the specialty chemicals, technologies and insights to help customers create new and improved products for today and sustainable solutions for tomorrow. Our chemistry is at work every day in a wide variety of markets and applications, including architectural coatings, automotive, construction, energy, personal care and pharmaceutical. Visit www.ashland.com to see the innovations we offer.
 
At Ashland our vision is to be a leading, global specialty chemicals company whose inspired and engaged employees add value to all we touch. In fact our people, employees, customers and vendors define who we are. They are the driving force behind everything we do.
 
Not only do we value our customers but we value our employees, and we work to offer them a dynamic and challenging environment. We hold ourselves to high standards at Ashland, and we value integrity and honesty.
 
Ashland has a history of attracting the best people and keeping them. The reasons are simple: industry competitive salary and benefits, pay-for-performance incentive plans and a diverse work environment where employees feel challenged and valued. People come to Ashland and stay. As a growing Fortune 500 specialty chemicals company, we offer opportunities for development and advancement throughout our global organization. Our values define who we are and what we care about as a company. If you are looking for a relationship with a company instead of simply a job, this may be a great fit.

Ashland is proud to be an Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Gender Identity/Sexual Orientation. 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability. NOTE:  We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have a signed recruiting agreement in place to fill a specific position.