Position Summary:The Sr. Quality Specialist will be responsible for contributing, supporting and maintaining the Quality System within the requirements of FDA's Quality System Regulations (QSR), EU regulations and ISO 13485 (ISO). This position is also responsible for providing QA support, where needed, in Document Control, QA Operations and Quality Systems. The Sr. Quality Specialist will also contribute to compliance activities of the Globus quality systems and participate in continuous improvement activities such as eQMS projects.
Essential Functions:- Support audit management.
- Support eQMS project management.
- Support Document Control functions within a Product Life Cycle Management (PLM) system.
- Issue Quality System documents and coordinate training process.
- Release and maintain QMS documents including the processing of new documents and revision requests.
- Ensure documentation is complete, properly formatted and meets corporate standards.
- Work with SMEs on gap analysis to ensure compliance with new and updated external standards.
- Manage equipment maintenance and documentation including calibrations and preventive maintenance.
- Report non-conformances and discrepancies.
- Generate Excel Spreadsheets.
- Participate in continuous improvement functions and implement changes for improvement.
- Perform database searches, data analysis, and reporting as required.
- Organize and communicate status of work to management and other personnel as required and to keep them informed of objectives and progress.
- Update and maintain Net Dimensions training system.
- 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 upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
- Other duties and responsibilities as necessary.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:- Bachelor's Degree.
- Experience performing file reviews and/or audits.
- QA or QC experience within the medical device, biotech or other regulated industry. preferred.
- Knowledge of GMP regulations preferred.
- Must be knowledgeable with Microsoft word and Excel programs.
- Must have ability to evaluate and interpret technical data.
- Must be able to lift at least 25 lbs.
- Strong typing skills, analytical skills, organizational skills and problem-solving techniques.
- Excellent communication and writing skills.
- Attention to detail.
- Ability to work independently with minimum oversight.
- Self-starter.
Physical Demands:The physical demands listed here are representative of those that must be met by an 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.
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.
