Lead Quality Engineer - Sterling Engineering, Inc.
Gurnee, IL 60031
About the Job
Position: Quality Manager
Location: Gurnee, IL 60031 onsite with 5% of domestic travel
I am looking for a Quality Manager or Quality Engineer to lead efforts in implementation and maintenance of a robust Quality Management System (QMS). In this role you will ensure compliance with global standards. Additionally, this role will oversee employee health and safety initiatives.
OVERVIEW OF RESPONSIBILITIES
Leadership for Quality and Safety Culture:
- Provide strategic and day-to-day leadership to foster a strong “Culture of Quality and Safety” throughout the organization.
- Promote continuous improvement and awareness of quality and safety principles.
Quality and Safety Management System:
- Manage all aspects of the QMS, ensuring alignment with FDA, ISO 13485, ISO 9001, MDD/MDR, MDSAP, Health Canada, OSHA, and ESAB Life Critical Standards.
- Lead efforts related to Good Manufacturing Practices (GMP) implementation and auditing.
Team Management:
- Lead a team of exempt and non-exempt employees.
- Ensure team members are well-versed in job-related Quality System procedures.
Supplier Quality Standards:
- Set clear quality standards for suppliers.
- Collaborate closely with internal teams and external suppliers to ensure incoming parts and components meet or exceed expectations.
Staffing and Motivation:
- Ensure the Quality team is appropriately staffed, trained, and motivated.
- Encourage a results-driven mindset and openness to new ideas.
Health and Safety:
- Conduct safety risk assessments.
- Enforce preventive measures to mitigate risks.
- Implement and maintain health and safety standards.
Metrics and Goals:
- Create and track safety-related objectives and metrics for the organization.
QUALIFICATIONS
- A minimum of 5+ years of progressive Quality experience in various-sized medical device organizations.
- At least 2 years of management experience with direct reports.
- 2 years of safety leadership experience.
- Bachelor’s degree in a relevant field (Life Sciences, Engineering, or Business).
- A master’s degree is a plus.
- Proficiency in English.
- Spanish language skills are a plus.
Overview: Sterling Engineering / Staffing has a rich history of delivering top talent to our clients. We are a nationwide Staffing Firm that has been in business for over 54 years. Currently serving over 200 active clients, Sterling works within the Automation, Energy, Facilities, Hospitality, Information Technology, Food, Logistics/Supply Chain, Manufacturing, Packaging, Life Sciences, Pharmaceuticals, Engineering and R&D industries.
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, Inc.