Quality Assurance / Regulatory Affairs Manager
Keystone provides development and contract manufacturing services for a wide range of medical device companies and initiatives. Market areas include imaging products, wound care, patient surfaces, and other Class I and Class II medical devices.
We are looking for a talented individual to join our dynamic and diverse Keystone Manufacturing team located in Kalamazoo, Michigan. This motivated self-starter must be capable of working with minimal supervision, have a "can do" attitude and be willing to do "whatever it takes" to complete assigned tasks efficiently and effectively. Eligible candidates must be highly organized with the ability to multi task with minimum interruption to work progress. Excellent interpersonal skills while working with high customer visibility are also critical to success with this opportunity.
As Manager of Quality Assurance and Regulatory Affairs you will provide leadership and direction to meet customer quality requirements, create, monitor and improve quality programs, reduce quality costs and maintain compliance within FDA regulations and ISO requirements. You will also be responsible for 510(k), CE Mark and other related regulatory product approval submissions. You will develop and nurture partnerships with internal and external customers as well as represent Keystone with interactions with the FDA and our ISO Certifying Body. We are excited by your ability to recognize and develop talent into leaders who share your passion for exceeding customer expectations.
• Minimum bachelor's degree in technical or scientific field.
• Minimum 5 years' experience in Quality / Compliance.
• Minimum 2 years' in a leadership role.
• Demonstrated experience in preparing 510(k) submissions for FDA
Preferred Skills / Qualification
• Ability to quickly understand new medical technology and manufacturing techniques.
• Certified Lead Auditor Internal / External Audits.
• Well versed in statistical and analytic techniques.
Reports to: President