This job has expired.
Essential Functions (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
- Manage improvement projects within Operations department
- Propose and implement improvements utilizing the CAPA and NC systems
- Support all departments to ensure compliance with the QMS and lead continuous improvement efforts of the QMS
- Provide support to all quality activities (i.e. CAPA, NC, Complaint, Change Control, Validation, etc.) via risk-based approach
- Support/Lead QMS audits (internal and external)
- Participant in Management Review (meeting and preparation)
- Work with Corporate Quality on projects
- Ensure alignment between local and corporate procedures
- Monitor quality objective status
- May assign tasks to and direct quality engineers and other quality staff
- May plan and coordinate detailed aspects of work within the quality department
- Other responsibilities as required
Competencies (Knowledge and Skills needed for this position.)
- Strong communication skills, written and verbal
- Problem solving skills and utilization of tools
- Solid understanding of ISO 13485 and 21 CFR 820
- Detail oriented
- Leadership skills
Desired Qualifications
Required Education:
BS Engineering and/or equivalent work experience
Experience:
2-5+ years of experience in quality engineering, quality control, quality improvement projects, root cause analysis, CAPA and/or relevant roles. 3+ years of medical device manufacturing and/or experience with 13485 preferred Certified Lead Auditor certification highly preferred (ISO 13485:2016 or ISO 9001:2015) Experience with Notified Body Audits highly preferred
Travel: as necessary (less than 5%)
Other:
Other Information
Direct reports:
n/a
Indirect reports:
n/a
Working Environment:
Open office environment, located near a manufacturing facility
Physical Demands:
Sitting, standing, lifting (no more than 40 lbs)
Position Type and Expected Hours of Work:
Full time position. Working Monday through Friday, with potential overtime and weekend support if necessary
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
#LI-Resound
This job has expired.
Get Hired Faster
Subscribe to job alerts and upload your resume!
*By registering with our site, you agree to our
Terms and Privacy Policy.
More Manufacturing and Production jobs
|
|
|
|
|
|