Overview
Quality Manager Jobs in Owatonna, MN at Quanex
True Health Inc.
Regional Quality Director
Department: Quality Assurance
Job Status: Full Time
FLSA Status: Salary-Exempt
Reports To: Director of Quality
Reasonable Accommodations Statement
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
True Health operates a fleet of plasma collection centers (thplasma) in New Jersey and Pennsylvania. We are expanding our Quality Team and seeking a Regional Quality Director to lead QA team in the plasma centers.
Essential Functions:
1. Ensure center QA Managers are inspection ready and adhere to Standard Operating Procedures, compliance policies and the Quality System
2. Guide, train and assist the center QA Managers to manage the QA tasks and programs
3. Streamline center processes resulting in improved quality, safety and customer relations
4. Ensure activities and controls used to determine the accuracy and reliability of the establishments’ personnel, equipment are maintained
5. Ensure compliance with all relevant regulations, laws, standards and company policies
6. Support center quality team to ensure all staff is competently performing their duties as evidenced by findings of a program of monitoring, tracking and trending of key metrics
7. Conducts internal audits of procedures and documentation
8. Participates with center QA management in CAPA development and implementing quality improvements at the centers
9. Provides feedback to staff on observations/inspections leading to improved adherence to cGMP standards
10. Works with Center Leadership to review the findings of various audits, CAPA if needed and successful closure of audits
POSITION QUALIFICATIONS
Bachelor’s Degree or equivalent work experience preferred
Three years supervisory experience overseeing the activities of others in a regulatory or quality environment
Knowledge of government and industry regulations, and ability to monitor compliance with these regulations
Experience working in a Quality Management System (QMS) preferred
PHYSICAL AND MENTAL WORKING CONDITIONS
Ability to make decisions, which have major impact on the company across all centers
Ability to understand, remember and apply oral and/or written instructions Must be able to see and speak with customers and observe equipment operation
Fast paced environment in a company seeking to expand quickly over the next few years
Potentially exposed to hazardous chemicals, extreme temperatures (-40° C) and to blood borne pathogens. Required to wear Personal Protective Equipment while performing specific tasks or in certain areas. Required to work extended hours to support company operational needs including limited travel to centers in the Philadelphia area
Job Type: Full-time
Pay: $80,000.00 – $100,000.00 per year
Benefits:
Dental insurance
Employee assistance program
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Holidays
Monday to Friday
Weekends as needed
Work Location: In person
Title: Quality Manager
Company: Quanex
Location: Owatonna, MN
