Quality Assurance Manager, Operations
Requisition Number: 73454
The company built on breakthroughs.
Join us.
Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the boundaries of what’s possible.
How do we do this? With our people. They break through limitations and expectations – not once in a career, but every day. They help move our company, and the world, forward.
At Corning, there are endless possibilities for making an impact. You can help connect the unconnected, drive the future of automobiles, transform at-home entertainment, and ensure the delivery of lifesaving medicines. And so much more.
Come break through with us.
As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning’s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.Purpose of Position:
Manage and maintain the execution of Quality and Regulatory operations at Life Sciences manufacturing, sterilization, and distribution locations; including all related activities to ensure that the products meet applicable requirements. Promote continuous improvement in customer satisfaction through inter-department communication, internal manufacturing specification understanding, sharing information, leadership of quality improvement projects. This role is focused on delivery the highest quality product in the market at the lowest possible price by rigorous adherence to manufacturing requirements and effectively implementing cost of quality culture.
Key Responsibilities :
Manage and provide leadership to the quality departments within LS manufacturing locations to ensure products meet both customer expectations and all applicable regulatory requirements.Ensure sites have effectively implemented the division-level Quality System requirements; ISO 9001, ISO 17025, ISO 13485, and 21 CFR Part 820, as needed.
Support receivership of the new product development process including plant resourcing, supplier/customer quality issue resolution for product realization.
Drive department or regional program/ project portfolio to meet immediate and ongoing business needs including ongoing management of applicable resources.
Frequently and effectively interact and resolve issues with peer-QARA leadership (i.e., team members) with little to no involvement from outside parties. Act as QARA integration point with manufacturing (Ops and engineering) for shared objectives and priorities. Effectively communicate impactful manufacturing issues/ actions with QARA peers to ensure all product, compliance, and customer needs are met.
Coach and develop all direct employees to ensure they can effectively oversee production of conforming product in the spirit of customer obsession.
Develop methods/metrics to evaluate and continuously improve process capability and product control plans; execute via collaboration with plant and division engineering. Provide oversight and ensure appropriate execution of the nonconforming materials program; ensure only highest quality parts are shipped to the customer using risk-based principles.
Education Required:
Bachelor’s Degree with technical discipline (e.g., Biology, Chemistry, Engineering, etc.) required; strong preference for candidates with a MBA or MS degree.
Minimum of 12 years’ experience in Quality Assurance or Regulatory with a minimum of 7 years in medical device/ biotech/ pharma.
Minimum of 5 years’ experience working in an active manufacturing environment.
Experience operating within regulated quality systems that are compliant with ISO 9001, ISO 13485, ISO 17025, and/ or 21 CFR Part 820, 210/211.
Demonstrated project management experience, including leading large-scale and/or multiple concurrent initiatives.
Minimum of 2 years’ experience managing operations across multiple manufacturing sites, with the ability to effectively prioritize competing, dynamic business needs.
Progressive leadership experience in operations, quality, and/or engineering, including supervisory or departmental leadership roles.
Proven ability to lead teams through continuous improvement initiatives, step‑change performance improvements, innovation, technical capability expansion, and organizational or work‑process change.
Strong communication, tactical thinking, and influencing skills, with the ability to effectively engage stakeholders at all levels, including customers and executive leadership.
High sense of urgency and accountability, with demonstrated success driving cross‑functional problem resolution and decision‑making related to manufacturing product quality; Conflict‑resolution experience preferred.
Demonstrated track record of developing talent and building strong pipeline talent, focused specifically on effectively demonstrating leadership principles that are aligned with organizational values.
Experience coordinating activities within functional areas and collaborating cross‑functionally to achieve business objectives.
This position does not support immigration sponsorship.
The range for this position is $160,886.00 - $221,219.00 assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education.
A job that shapes a life.
Corning offers you the total package.
Your well-being is our priority. Our compensation and benefits package supports your health and wellness, financial aspirations, and career from day one.
- Company-wide bonuses and long-term incentives align with key business results and ensure you are rewarded when the company performs well. When Corning wins, we all win.
- As part of our commitment to your financial well-being, we provide a 100% company-paid pension benefit with fixed contributions that grow throughout your career. Combined with matching contributions to your 401(k) savings plan, Corning’s total contributions to your retirement accounts can reach between 7% and 12% of your pay, depending on your age and years of service.
- Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family.
- Getting paid for our work is important, but feeling appreciated and recognized for those contributions motivates us much more. That’s why Corning offers a recognition program to celebrate successes and reward colleagues who make exceptional contributions.
We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, veteran status or any other legally protected status.
Corning is committed to providing equal employment opportunities and considers requests for reasonable accommodations in accordance with applicable laws. Individuals with disabilities or sincerely held religious beliefs may request reasonable accommodations to participate in the application or interview process, perform essential job functions, or access other benefits and privileges of employment. To submit a request for reasonable accommodation related to disability or religion, please contact us at [email protected] .
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