Quality Engineer

Lower Providence Township, PA, United States

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.

Branch Medical Group, a subsidiary of Globus Medical Inc., manufactures a wide range of implants for spinal and orthopedic applications as well as to design the instrumentation cases that house them. Our passion, combined with Globus’ world-class engineering, transforms clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care and understand that speed is critical because life cannot wait.

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Position Summary :

The Quality Engineer is responsible for providing leadership in achieving the highest level of manufacturing quality and quality system performance while ensuring compliance with all company policies and procedures and maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system requirements. Characterized as an excellent problem solver, this person will thrive in an organization with high expectation levels and play an integral role in developing, maintaining, and improving the quality management system, product quality, and manufacturing process quality.

Hours: 7:30 am to 3:30 pm

Essential Functions :

Develops, supports, and maintains product risk management and risk analysis activities to ensure quality objectives are met

Leads, develops, supports, and maintains process FMEAs and control plans

Oversees 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

Assists in the development, implementation, and improvement of production monitoring methods and systems for product inspection and testing

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 to provide direction for corrective and preventive actions and/or process improvement activities

Addresses customer complaints by conducting investigations

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

Utilizes 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

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, Engineering or Science related field preferred

Minimum four years of progressive work experience in quality assurance with a background in quality engineering, process quality, statistical quality control, and risk management.

Minimum two years working in a quality engineering position

Strong knowledge of GMP and ISO regulations

Experience with MS Office and statistical analysis tools

Knowledge of Lean Manufacturing, Six Sigma, and reliability engineering is a plus

ASQ certifications preferred

Excellent verbal and written communication skills

Attention to detail

Self-starter

Advanced critical thinking and problems-solving skills

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; climb or balance; and stoop, kneel, crouch or crawl

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.

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