Quality Specialist

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

Salary : $60,000 - $70,000