QS Specialist

Erbe Medical, LLC; Tempe (AZ); On-site; USD 70,000 - 100,000; Full time

Job summary

Erbe Medical, LLC in Tempe, AZ is seeking a Quality Systems professional to support the QMS, CAPA, Design Control, Change Control and Records Control, ensuring regulatory compliance with FDA 21 CFR 820 and ISO 13485. You will assist with document control, training records, audits, and ongoing system improvements while maintaining cGMP and GDP standards, and coordinating with cross-functional teams.

This role requires 2–5 years in Quality Systems and a high school diploma; bilingual Spanish

Qualifications

• 2–5 years of experience in Quality Systems.
• Experience in medical device or regulated industry.
• QMS experience required.
• Bilingual Spanish preferred.

Responsibilities

• Assist development, implementation, and monitoring of QMS including CAPA.
• Support Design Control, Change Control, Document Control and DHR.
• Provide training on document control processes.
• Participate in internal and external audits.
• Ensure compliance with FDA/ISO requirements.
• Maintain training records and CCP/QRR processes.

Skills

QMS experience

Document control

CAPA

Audits

Regulatory compliance

Bilingual Spanish

Education

High School Diploma

Tools

MS Office

Job description

Essential Responsibilities

This position will assist with the development, implementation, and monitoring of the Quality Management System (QMS) to include the Corrective and Preventive Action (CAPA) System, Design Control, Change Control and Records Control, Document Control, Training Records, Device History Records (DHR) and various other elements within the quality systems as it relates to regulatory compliance and Erbe Quality Systems. Additionally, this position will guide various other facets of the quality system, actively supporting system integrity, continuous improvement, and adherence to international medical device standards such as FDA 21CFR820 and ISO 13485.

• Provide support for the release and control of documents including updating current and archiving obsolete QMS documents.
• Process document control changes and route new/updated documents for proper approvals. Documents include process instructions, forms and other documents for all areas of the business.
• Provide training to individuals on related document control processes.
• Ensures document changes are compliant with regulatory QMS and regulatory requirements.
• Creates and revises job-specific training records, which list applicable Procedures, Work Instructions and Forms that are assigned to each specific job title.
• Ensures current and previous revisions of Controlled Documents are properly maintained and controlled according to Erbe QMS requirements.
• Participate in internal and external audits.
• Support company goals and objectives, policies and procedures, current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and FDA regulations
• Revise documents and maintain revision control per FDA/ISO requirements.
• Drive improvements and change to the Quality System Processes including implementation of Electronic Data Management Systems (EDMS) All other duties as assigned by the Quality Manager.
• Establish and maintain training records.
• Coordinate Change control process (CCP) and Quality Review requests (QRR).
• Receive and coordinate incoming complaints from internal customers.
• Assist with review of DHR and final acceptance and release.
• Assist with Quality Control testing activities as required.

Supervisory Responsibility

This position is an individual contributor and has no direct supervisory responsibility.

Work Environment

This position operates in an office and manufacturing environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. The position also interacts with machinery on the manufacturing floor and numerous devices that are sold by the company.

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. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and stoop; use hands to finger, handle or feel; and reach with hands and arms. The employee frequently is required to lift and/or carry up to 20 pounds. For more information, please refer to the Position Analysis/Physical Activities Checklist on file in Human Resources.

Position Type and Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, 7:30 a.m. to 4 p.m. Occasional evening and weekend work may be required as job duties demand.

Travel

This position requires no measurable travel.

Required Education and Experience

• High School Diploma
• 2-5 years of experience in Quality Systems
• Medical device industry (particularly ISO 13485) or a regulated industry experience preferred
• Quality Management Systems (QMS) experience required
• Bilingual (Spanish) is highly preferred

Position Requirements

• Excellent verbal and written communications required; strong facilitation and interpersonal skills required.
• Must be able to communicate complex information to all levels within the organization.
• Demonstrated high quality computer skills including MS Office.
• Must be detail-oriented and produce high quality work in a high-volume environment.
• Must be able to handle confidential information in an appropriate and professional manner.
• Ability to remain flexible and open to change within a fluid global industry.

Competencies

• Problem Solving/Analysis.
• Results Driven.
• Detail Orientation.
• Customer Focus.
• Technical Capacity.
• Communication Proficiency.

Additional Eligibility Qualifications

None required for this position.

Work Authorization/Security Clearance

Employees must be legally authorized to work in the United States. Employees must not be specifically barred from working with Federal contracts, government entities or otherwise listed on excluded parties list as maintained by the Federal government.

AAP/EEO Statement

Erbe employees and applicants for employment are protected by federal laws, Presidential Executive Orders, and state and local laws designed to protect employees and job applicants from discrimination on the bases of race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service or other non-merit-based factors. These protections extend to all management practices and decisions, including recruitment and hiring practices, appraisal systems, promotions, and training and career development programs.

Other Duties

Please note this position 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.

At-Will Employment

This position description does not constitute a contract or guarantee employment for any specified time. The company may exercise its employment-at-will rights at any time.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.