Quality Systems Specialist

Limerick, PA

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!

Position Summary: 

Provide leadership in achieving the highest quality 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. 

As a key contributor to the quality organization, this professional will be a self-motivated and assertive individual.  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.

Responsible for development, implementation, and continual improvement of quality systems and procedures supporting all business processes including but not limited to, the monitoring, measurement, analysis and improvement processes needed to demonstrate conformity of product, ensure conformity of the quality management system, and maintain the effectiveness of the quality management system. 

The responsibilities of the position include, but are not limited to, the following:

  • Develop and maintain quality systems, processes, and procedures
  • Manage and maintain the corrective and preventive action system by reviewing and prioritizing CAPA requests for completeness, coordinating CAPA tasks as appropriate, and compiling CAPA metrics for reporting
  • Manage and maintain the Supplier Corrective Action Request (SCAR) system by reviewing and prioritizing SCAR requests for completeness, coordinating SCAR tasks as appropriate, and compiling SCAR metrics for reporting
  • Manage and maintain the Customer Complaint system by ensuring the complaints are promptly and thoroughly evaluated, coordinating tasks as appropriate, reviewing complaint files for completeness, and compiling Complaint metrics for reporting.
  • Lead Material Review Board meetings.
  • Manage and maintain the Supplier Qualification process, by reviewing Supplier requests for completeness, coordinating supplier qualification task as appropriate, ensuring all necessary documentation and actions have been taken, and updating Approved Supplier Lists and files as necessary.
  • Manage and maintain the Company’s internal and external quality audit process and schedules.
  • Perform internal and external audits as necessary.
  • Provide training to other departments on quality management system requirements as necessary.
  • Assist in preparation for and support of external regulatory and notified body audits
  • Gather and prepare data for management review meetings.
  • Provide written and oral reports to supervisor or other management personnel to keep them informed of activities and results.
  • Maintain a cooperative and motivational attitude with co-workers.
  • Perform other tasks as requested by supervisor to meet business goals and objectives.
  • Adhere to all Company policies, rules, procedures and housekeeping standards.

 

In order to be qualified for this role, you must possess the following: 

Education:  Requires a bachelor’s degree (science or engineering preferred).

Experience:  At least two years of relevant experience in quality assurance.  Experience in the medical device industry preferred.  Candidates for this position will have at least 2 years of related progressive work experience with a background in quality systems.  Candidates must be able to work independently and on teams.

Other Duties:

GMP and ISO knowledge preferred.  Computer proficiency with MS Office is required.  Multi-discipline assurance background is desired.    Must be able to make solid decisions that effectively support the business and company policies.  Travel requirements are as needed.  

Physical Demands:

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.

 

JOB CODE: 1002060