Quality Assurance Manager - Sterling Engineering
Gurnee, IL
About the Job
Title: Quality Assurance Manager
Location: Gurnee, IL
Hire Type: Direct Hire
Target Salary Range: $110K - $120K/year base, plus bonus
Overview:
Sterling has helped build careers for thousands for professionals like yourself. Our expert recruiters support you at every step in the process and as a Best of Staffing company, Sterling provides exciting work with exceptional employers across the U.S.
Job Summary:
The Manager of Quality is responsible for all aspects of the Quality Management System and its adherence to global standards in addition responsible for employee health and safety.
Job Duties:
- Will manage a team of Quality Supervisors who oversee quality control, parts inspections, and document control personnel.
- Responsible for providing strategic and day-to-day leadership, as well as maintaining a high degree of quality, safety awareness, and continuous improvement throughout the organization.
- Manages all aspects of the Quality Management System for the corporation and ensures the company complies with all applicable standards, regulations, and customer requirements including but not limited to FDA, ISO 13485, Health Canada, and OSHA.
- Leads the company’s efforts for GMP including their implementation and auditing to ensure the company is always compliant and continually improving.
- Sets clear quality standards for Suppliers and works closely and collaboratively with the internal organization and external suppliers to ensure incoming parts and components meet and/or exceed our expectations.
- Ensures that the Quality team is appropriately staffed and trained.
- Conduct safety risk assessments and enforce preventive measures.
- Implement and maintain health and safety standards.
- Create and track safety-related objectives, metrics, and goals for the organization.
- Additional related duties.
Qualifications:
- Bachelor’s Degree in Life Sciences, Engineering or Business preferred.
- 5+ years of progressive Quality Assurance experience in medical device or pharmaceutical manufacturing organizations.
- Minimum 2 years of Management experience with direct reports.
- Must be familiar with FDA, ISO 13485, and 21CFR standards and regulations.
- Experience with Validation (process, facility, etc.), IQ/OQ/PQ, and CAPA are highly desired.
- Must reside within a commutable distance from Gurnee, IL and be available to work onsite.
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.
Source : Sterling Engineering