Quality Systems Specialist

A Hiring Company; Indianapolis (IN); On-site; USD 52,000 - 76,000; Full time

Job summary

A Hiring Company is seeking a Quality Assurance Associate to independently perform quality functions within the Quality Department, overseeing document control, CAPA, audits, and complaint handling.

The role requires an Associates degree or equivalent plus 3–5 years in medical device manufacturing, with strong regulatory knowledge and skills in Word, Excel, and Outlook. Effective communication and training abilities are essential for cross-functional collaboration.

Qualifications

• Associates degree or equivalent; or 3–5 years related experience in medical device manufacturing.
• Proficient with ISO 13485, FDA regulations, and related quality systems.
• Ability to read, analyze, and interpret general business documents and regulations.
• Strong writing skills for reports, SOPs, and procedures.
• Effective presentation and communication with diverse stakeholders.
• Experience with Word, Excel, and Outlook for documentation and communication.
• Demonstrates time management and independent work habits.

Responsibilities

• Review customer complaints and CAPA cycles.
• Lead internal audit program and document control activities.
• Assist in SOP development, revision, and document control.
• Identify training needs and conduct QA-related training with the Quality Manager.
• Investigate nonconformances, root cause analysis, and corrective actions.
• Support QMS maintenance and data entry to sustain production schedules.

Skills

Regulatory knowledge

Report writing

Communication skills

Time management

Attention to detail

Analytical reading

Education

Associates degree or equivalent

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

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:

• Associates 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
• Reaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing and repetitive motions
• Proficiency in Microsoft Word, Excel, and Outlook or similar e‑mail programs
• Responsible for adhering to the quality system and good manufacturing procedures
• Must be able to communicate effectively with the manager and co-workers to provide and receive direction
• Demonstrate good time management skills independent of supervision
• Maintain timely and regular attendance per company policy

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