At Globus, we move with a sense of urgency to deliver innovations that improve the quality of life of patients, inspired by the surgeons and healthcare providers who treat them.
Our world-class engineering works to transform clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care, and we understand that speed is critical because life cannot wait. Join us!
The Quality Supervisor is responsible for providing leadership and direction to quality inspectors to ensure purchased materials and manufactured products are of the highest quality level 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. In addition, this position will oversee and monitor the inspection and testing of materials, purchased parts, and manufactured products and assemblies to ensure adherence to established quality standards.
The responsibilities of the position include, but are not limited to, the following:
- Directing and supervising the Quality inspection functions within the manufacturing facility
- Supervising the activities of employees in Quality and ensures compliance to procedures
- Ensuring purchased materials and manufactured products conform to specifications and quality standards
- Conferring with purchasing, customers, and vendors regarding specifications, errors, problems, complaints, compliance with government regulations, international standards and company requirements
- Performing quality control inspections on incoming materials and manufactured products
- Coordinating and dispositioning non-conforming material as part of MRB
- Supporting the activities associated with addressing customer complaint investigations
- Assisting with equipment qualification on new inspection equipment
- Assisting Manufacturing and Engineering in implementation of new procedures, equipment, and methods as related to quality of product and cost reduction
- Assisting Manufacturing, and Engineering in identifying quality requirements and problems for the improvement and establishment of new and existing products, procedures, processes and methods
- Performing periodic vendor and internal audits to ensure system conformance, effectiveness and accuracy
- Identifying, developing, and providing training for Quality Assurance and Manufacturing, as needed, as related to Quality Assurance
- Providing support and expertise in the implementation and enforcement of ISO 13485, ISO 14971 and FDA Quality System Regulation
- Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure 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
- Representing 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 of Globus
In order to be qualified for this role, you must possess the following:
- Bachelor’s degree or relevant experience plus a high school diploma
- Minimum of 2-5 years related experience including leading others, Minimum 5-8 years inspection experience in a manufacturing environment, preferably with a manufacturer of medical devices.
- Computer proficiency with MS Office and statistical analysis tools
- Excellent communication and interpersonal skills
- Strong planning skills, the ability to motivate others and resolve production issues
- cGMP and ISO knowledge strongly preferred
- Quality assurance background and ASQ certifications preferred
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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Globus Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.