Overview
Quality Manager Jobs in Columbus, IN at TA Dispatch
About us
CryoConcepts is a global leader in the development, manufacture and sales of cryosurgical, cryotherapeutic products. Around the world the company supplies a variety of professional and OTC products to physicians, veterinarians and OTC consumers. The Company is seeking the right person to join our Quality/Regulatory group. The right candidate will be joining a fast paced organization where they can gain experience working in a variety of areas.
Primary responsibilities:
· Manage QMS documentation and quality records
· Review quality records and perform batch record review for final release of product
· Identify essential documentation concerns, discrepancies or compliance issues
· Process documents within electronic quality management systems and act as eQMS administrator
· Assist with and ensure completion of Nonconformance and Planned Deviations
· Participates in the Corrective and Preventative (CAPA) process, including investigations, root cause analysis and action plan assignment. Tracks and monitors CAPA investigation, CAPA plans, implementation, and surveillance
· Coordinates the execution of the Calibrated Equipment Program
· Perform product complaint entries, product complaint investigations, product complaint close out reports and participate in product complaint review calls with customer(s)
· Assist in analyzing company data, including customer complaints and non-conformance reports (NCRs), for patterns or trends; identify potential problems before they occur
· Maintains the data collection and reporting of specified quality metrics and key process indicators; assist with data review and preparation for management review
· Prepare and assist with company audits by outside organizations
· Manage training documentation
Qualifications:
· Bachelor’s degree with related experience in quality
· 3+ years’ experience in a related industry (medical devices preferred)
· Experience with quality management systems
· Thorough knowledge and understanding of FDA 21 CFR Part 820, ISO 13485:2016 and MDSAP
· Experience with an electronic document management system
· Strong Microsoft office skills, Strong organization and time management skills
· Strong problem-solving and multi-tasking skills, Demonstrated written and verbal communication
Job Type: Full-time
Pay: $60,000.00 – $70,000.00 per year
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Parental leave
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Work Location: In person
Show more
Title: Quality Manager
Company: TA Dispatch
Location: Columbus, IN
