Quality Systems Specialist

Vonco Products LLC; Indianapolis (IN); On-site; USD 52,000 - 78,000; Full time

Job summary

Vonco Products LLC is seeking a Quality Assurance professional to independently perform quality-related functions within the Quality Department. The role focuses on maintaining and monitoring quality systems, including document control, change control, CAPA, internal audits, and complaint handling.

The position requires an Associate degree or equivalent, 3–5 years of related experience in medical device manufacturing, and proficiency with ISO 13485 and FDA regulations.

Qualifications

• Experience with medical device quality systems is required.
• Ability to read, analyze, and interpret governmental regulations and standards.
• Ability to write reports, procedures, and business communications.
• Excellent communication skills with coworkers and supervisor.

Responsibilities

• Manages review cycle of customer complaints and CAPAs.
• Lead internal audit program.
• Assist in development and control of SOPs and related documents.
• Identify training needs and conduct QA-related training with Quality Manager.
• Facilitate nonconformance processes with timely investigations and root-cause analyses.
• Support maintenance of the Quality Management System.
• Support performance metrics for continual improvement.
• Assist with inspections, document reviews, and data entry to maintain production/quality timelines.

Skills

Regulatory knowledge

Technical writing

Data interpretation

Communication

MS Office proficiency

Education

Associate degree or equivalent

3–5 years related experience

Tools

MS Office Suite

Job description

Basic Purpose and Function

Independently perform quality-related functions within the Quality Department. Maintain and monitor quality systems, including document control, change control, CAPA (Corrective and Preventive Actions), internal audits, and complaint handling.

Job Responsibilities

• Manages the review cycle of customer complaints and CAPA’s
• Lead internal audit program
• Assist in the development, revision, and control of Standard Operating Procedures (SOPs) and other controlled documents.
• Identify training needs and conduct Quality Assurance-related training to associates in tandem with the Quality Manager
• Facilitate the nonconformance process and ensure timely investigation, root cause analysis, and resolution.
• Supports the maintenance and upkeep of the Quality Management System
• Support performance metrics system for continual improvement
• Assist with inspections, document reviews, and data entry when additional support is required to maintain production or quality timelines

Other Responsibilities

• Responsible for adhering to the quality system and good manufacturing procedures
• Must be able to communicate effectively with the supervisor and co-workers to provide and receive directions
• Demonstrate good time management skills independent of supervision
• Maintain timely and regular attendance per company policy
• Performs other duties as assigned

Qualifications

• Associate’s degree or equivalent; or 3-5 years related experience and or training; or equivalent combination of education and experience in medical device manufacturing
• Proficient in applicable regulations/standards (ISO 13485, FDA, etc.)
• Ability to read, analyze, and interpret general business periodicals, professional journals, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals
• Ability to effectively present information and respond to questions from employees, supervisors, managers, executive staff, customers, and suppliers
• Proficiency in Microsoft Word, Excel, and Outlook or similar e‑mail programs

Physical Requirements

• Reaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing and repetitive motions
• The associate must occasionally lift and/or move up to 40 pounds
• Specific vision abilities required by this job include close vision and the ability to adjust focus

Equal employment opportunity, including veterans and individuals with disabilities.