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Quality Assurance Specialist II

2 months ago

Northbrook, Illinois, United States Michael Page Full time
Position Overview

We are seeking a dedicated Quality Assurance Specialist II to join our dynamic team. This role offers a
  • Flexible Work Environment & 15% Bonus
  • Opportunity to work with an industry leader in the Medical Device sector
About the Company

Our client is a prominent manufacturer in the medical device industry, committed to delivering exceptional products that enhance patient care and improve quality of life globally. Their advanced manufacturing facility is equipped with cutting-edge technology and staffed by a team of skilled professionals dedicated to maintaining the highest standards of quality throughout the production process.

Specializing in a wide range of medical devices utilized in various fields such as orthopedics, cardiology, and neurology, the company prides itself on its ability to meet the specific needs of customers and their patients. They believe that innovation is crucial for success in the medical device arena and continuously seek new methods to enhance their products and manufacturing practices. A strong emphasis is placed on research and development to remain at the forefront of the industry.

Committed to sustainable and responsible manufacturing, the company strives to minimize environmental impact while operating ethically and socially responsibly. Their mission is to positively influence the lives of patients worldwide by providing high-quality medical devices that improve health outcomes and enhance overall quality of life.

Key Responsibilities
  • Oversee a Quality department consisting of 20 members, including 6 direct reports
  • Lead customer interactions and address customer complaints
  • Conduct root cause analyses and implement corrective and preventive actions
  • Manage product and process validations: IQ, PQ, OQ
  • Monitor and document departmental KPIs and metrics
  • Maintain ISO 13485 Quality Management System
  • Conduct front room audits
Ideal Candidate Profile
  • Proven experience in customer interfacing
  • Expertise in leading root cause investigations
  • Experience in driving CAPA initiatives
  • Familiarity with validation processes
  • Proficient in tracking and documenting KPI data
  • Excellent verbal and written communication skills
  • Adept at cross-functional collaboration
  • Knowledge of ISO 13485 standards
Compensation and Benefits
  • Competitive base salary ranging from $110,000 to $135,000
  • Comprehensive health, dental, and vision coverage
  • Performance-based bonus up to 15%
  • Three weeks of vacation
  • 401k plan with a 7% match
  • Benefits commence on the first day of employment
  • Personalized development plan available
  • Additional benefits upon request