Quality Manager
Ashland, Columbus, OH, United States
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
Equal Opportunity Employer Statement
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.
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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
Equal Opportunity Employer Statement
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.
#J-18808-Ljbffr