Quality and Compliance Manager

Quality and Compliance Manager

Carestream Health manufacturing is seeking a Quality Manager and Compliance Manager rolled into one at its 1049 Ridge Road digital facility.

Location : 100% ONSITE at 1049 W. Ridge Road, Rochester, NY (Rt. 104 / Greece)

The goal of the Quality Manager is to provide leadership to their team assuring compliance and quality standards of our process. Use knowledge of process and parts defects to drive root cause and corrective action so that we do not have repetitive failures. Work with teams and vendors to verify parts are in tolerance and can be used successfully in assembly. Tracking these parts through the manufacturing system for traceability and ensure records are maintained to meet global system requirements including but not limited to 21 CFR 820, ISO 13485, ISO 9000, MDSAP and the Canadian and EU medical Device Regulations.

Required Skills & Education :

• BS in Science or other technical discipline.
• 5+ years directly relevant experience in a medical device or pharmaceutical quality assurance setting, or equivalent industry experience.
• Knowledge of quality system standards and regulations : FDA QSR, ISO 9000 and ISO 13485 standards, etc.
• Communication skills to convey information in meetings, reports, and status updates.
• Demonstrates excellent written, oral, and interpersonal skills with personnel at all levels.
• Exhibits a high degree of integrity, initiative, and teamwork.
• Strong leadership skills driving continuous improvement and compliance.
• Knowledge of the product to ensure accurate quality control.
• Analysis, critical thinking, and problem-solving skills to review systems, find flaws, and pose solutions.
• Ability to multitask and operate under deadlines while still meeting standards.

Desired Skills :

Work Environment :

Manufacturing, labs and offices surrounding.

Carestream is an Equal Opportunity Employer. Carestream is an equal opportunity organization. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, gender identity, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

All applicants must complete the on-line application process. Carestream is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please click accommodations at accommodations@carestream.com .