- This range reflects Carestream's good faith estimate to pay fairly as starting wage. Offers will be tailored within the range based on the selected candidate's experience, industry knowledge, technical and communication skills, and other factors that may prove relevant during the interview process, as well as geographic market differentials for the position.
- BS in science or other technical discipline (Engineering, Statistical, Quality Control Management).
- 5+ years directly relevant experience in a medical device or pharmaceutical quality assurance setting, or equivalent industry experience (equivalent: leading a group in another organization in the area of QC, Compliance and/or Regulatory).
- 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.
- Six Sigma Black Belt Certification
- ASQ Certifications (ex: Audit/Engineer/Manager/Software)
- Trained Quality System Auditor for GMP and/or ISO audits
- Experience with FDA inspections
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Quality Manager - Rochester, United States - Carestream Health
Description
Innovation that sparks imagination. Continue on to your next challenge with us.Carestream is a worldwide provider of medical imaging systems and solutions; x-ray imaging systems for non-destructive testing; manufacturing of film and precision contract coating services for a wide range of industrial, medical, electronic and other applications-all backed by a global service and support network.
Carestream's diagnostic imaging technology systems are at work in 90 percent of hospitals worldwide.At Carestream, we offer a global perspective and a world of opportunities for people who have the desire to make a positive impact.
Join our global team of 3,000+ professionalsCompensation is a range of $132,200 to $150,000.00 plus benefits.
Position Summary:
The goal of the Quality Manager is to provide leadership to their team assuring compliance and quality standards of our process (6+ direct and 18+ indirect team members).
Use knowledge of process and parts defects to drive root cause and corrective action so that we do not have repetitive failures.
Work with manufacturing, engineering and finance 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.
Attend 2 to 3 monthly global evening calls.Location: 100% ONSITE at 1049 W. Ridge Road, Rochester, NY (Rt. 104/Greece).
If your not from the Rochester, NY area and fit the required skills below, we would discuss a possible relocation.
Required Skills & Education:
Desired Skills:
Work Environment:
Manufacturing, labs and offices surrounding.
Physical Requirements:
Standing: 1-25%
Walking: 1-25%
Sitting: 1-25%
Bending: 1-25%
Lifting up to 20 pounds: 1-25%
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.
Applying for a job with CarestreamAll 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
Requisition ID: 3847
Nearest Major Market:
Rochester
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