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Senior Quality Manager

4 months ago

San Antonio, 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 Senior Quality Manager will work within the Quality Department to assist in compliance activities of the quality system and participate in continuous improvement activities. The primary function of this position will be to oversee Quality Assurance and Quality Control activities and participate in the development, documentation, monitoring, and maintenance of quality systems for conformance to regulatory requirements and company policies and procedures. The Senior Quality Manager provides leadership to other quality team members and acts as a liaison to the Director of Quality. The position responsibilities may include the following, although other duties and responsibilities may be assigned as necessary:

Essential Functions:
  • Manages day to day activities for Quality Assurance.
  • Oversees the document control process and ensure all Document Control Orders (DCO) are properly implemented within established time limits. Reviews and approves all DCOs ensuring all Quality System elements are met.
  • Ensures unprocessed donors released for production meet processing needs.
  • Ensures production records reviewed and released to finished goods meet daily Manufacturing and Distribution priorities. Assists in the review of records as needed to meet set goals.
  • Oversees the CAPA system to ensure all reports are promptly and thoroughly evaluated and closed within established time limits. Aids investigating departments in investigation and development of proper Root Cause Analysis as needed.
  • Manages the QA review and closure of all applicable BBA logs, test results, certs, etc., ensuring all are reviewed appropriately and within established time limits.
  • Prepares Quality System monitoring reports, metrics, trends, and graphs.
  • Ensures all annual SOP, training and Management meeting requirements are met.
  • Participates in continuous improvement and ensure needed changes are implemented and monitored for effectiveness.
  • Oversees the QA Audit Specialist and ensures internal and external audit schedules are maintained, all required registrations, accreditations, and licensures are maintained current. Oversees the Supplier Management program.
  • Participates in client audits of BBA, and assists as necessary in Regulatory audits of BBA (FDA, AATB, KFDA, etc).
  • Develops and maintains a Quality Assurance staff training system to include schedules, curriculum, and plans and ensure Quality Assurance staff are trained accordingly.
  • Oversees Quality Control.
  • Assists the Quality Control Manager with coordinating day to day activities for QC, as needed.
  • Ensures equipment calibration and preventative maintenance is scheduled and final reports are reviewed for accuracy and completion.
  • Ensures cleanroom qualifications are scheduled and reports are reviewed for accuracy and completion.
  • Reviews and approves Quarterly Dose Audit results and summary documentation.
  • Confirms QC monitoring reports, metrics, trends, and graphs are maintained and accurate.
  • Oversees the environmental monitoring program according to current schedules.
  • Ensures product and packaging QC testing is completed appropriately.
  • Oversees facility monitoring systems of temperature, humidity and pressure.
  • Ensures all facility and equipment monitoring logs are reviewed appropriately.
  • Ensures accurate EM/QDA/Calibration data is maintained.
  • 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:
  • High school diploma or GED is required. Bachelor's degree in a related field or equivalent work experience preferred.
  • Ability to speak, read, and write in English is required.
  • 5+ years experience in tissue banking or related field.
  • 5+ years managing Quality Management Systems
  • Knowledge of GMP regulations
  • Must be proficient with Microsoft Word, PowerPoint and Excel programs.
  • Strong typing skills, analytical skills, and problem solving techniques.
  • Excellent communication and writing skills.
  • Certified Tissue Banking Specialist within 1 year
  • Certified Quality Manager/Operational Excellence certification within 2 years.
  • Must be a flexible team player capable of working in a deadline driven environment
  • Self-starter
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 25 pounds, and occasionally lift and/or move up to 60 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: 1003538