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Quality Engineer

3 months ago

Royersford, United States Globus Medical Full time

About Us:

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.

Position Summary:

The Quality Engineer is responsible for development, implementation, and continual improvement of quality systems and procedures supporting all business processes including, but not limited to, product design and development, manufacturing operations, supplier management, documentation and records, training, quality management, and auditing. Additionally, this individual will develop, support, maintain, and improve production processes and controls using a foundation of engineering principles, risk management and risk analysis, and statistical quality control methods.

Essential Functions:

  • Develops, supports, and maintains product risk management and risk analysis activities to ensure quality objectives are met
  • Develops, supports, and maintains process FMEAs and control plans
  • Support process optimization using design of experiments (DOE) and retrospective data analysis to understand and minimize sources of process variation affecting products. Identifies key process input variables and key process output variables
  • Support the development, implementation, and improvement of production monitoring methods and systems for product inspection and testing
  • Support activities associated with measurement systems analysis
  • Validates manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)
  • Monitors and analyzes production information to support risk management and provide direction for corrective and preventive actions and/or process improvement activities
  • Applies Lean Six Sigma and Business Process Management concepts to eliminate waste, improve throughput, improve quality, and reduce cost
  • Develops, improves, and maintains quality systems and tools for quality tracking, analysis, reporting, problem solving, and process improvement
  • Uses concepts of probability and statistical quality control to guide decisions
  • Communicates quality objectives
  • Integrates quality engineering methods to support co-workers and business objectives for product and process quality and problem resolution
  • Performs internal and external audits
  • Establishes, follows, and improves company procedures
  • Provides written and oral reports to supervisor or other management personnel to keep them informed of activities and results
  • Maintains a cooperative and motivational attitude with co-workers
  • Performs other tasks as requested by supervisor to meet business goals and objectives
  • Adheres to all Company policies, rules, procedures and housekeeping standards
  • Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
  • Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications:
  • Bachelor's degree required - Science or Engineering degree preferred
  • 4 years of progressive work experience in Quality Assurance
  • Experience in Medical Device industry preferred
  • Background in process quality, statistical quality control, and risk management
  • Able to work as an independent contributor as well as within a team
  • GMP and ISO knowledge required
  • Proficiency in using Microsoft Office products and statistical analysis tools is required
  • Multi-discipline assurance background is desired
  • Knowledge of Lean Manufacturing, Six Sigma and reliability engineering is a plus
  • ASQ certification is preferred
  • Must be able to make solid decisions that effectively support the business and company policies
  • Add Software/Technology required/preferred
  • Attention to detail
  • Ability to travel up to 5% of the time
Our Values:

Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
  • Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions
  • Customer Focused: We listen to our customers' needs and respond with a sense of urgency
  • Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger
  • Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Physical Demands:

The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.
  • Required to sit, stand, walk, climb or balance; and stoop, kneel, or crouch as necessary
  • Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds

Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.

Equal Employment Opportunity:

Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees' talents and support an environment that is inclusive and respectful.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

JOB CODE: 1003645