Job Title: Quality & Document Control Analyst
Position Summary:
The Quality & Document Control Analyst supports the organization’s quality assurance activities while managing and maintaining controlled documentation. This hybrid role ensures compliance with quality standards, regulatory requirements, and internal procedures, while maintaining accurate, organized, and audit-ready documentation. This position plays a key role in inspections, process monitoring, and document lifecycle management to support operational excellence and continuous improvement.
Essential Job Functions:
Inspection & Testing Execution
· Perform incoming, in-process, and final inspections in accordance with approved procedures and specifications.
· Conduct dimensional, visual, and functional testing using calibrated measurement equipment.
· Verify product conformance to drawings, BOMs, work instructions, and quality standards.
· Identify, document, and segregate nonconforming material in accordance with established procedures.
Documentation & Record Control
· Maintain document repositories in accordance with the Document Control procedures and ISO requirements.
· Manage the document change and approval process.
· Accurately complete inspection records, test reports, and quality documentation in compliance with ISO and internal requirements.
· Ensure proper labeling, traceability, and status identification of materials and finished goods.
· Maintain organized quality records to support audit readiness and regulatory compliance.
· Support document control by following approved revisions and reporting discrepancies.
Nonconformance & CAPA Support
· Initiate Nonconformance Reports for identified defects or process deviations.
· Assist in root-cause investigations by gathering data, photographs, and inspection evidence.
· Verify implementation of corrective actions through follow-up inspections and documentation review.
· Monitor recurring issues and escalate trends to Quality leadership.
Calibration & Equipment Control
· Verify that measurement and test equipment are within calibration prior to use.
· Maintain calibration logs and coordinate with approved vendors for scheduled calibration activities.
· Report damaged or out-of-tolerance equipment immediately.
Production & Cross-Functional Support
· Work closely with Production and Engineering to clarify specifications and resolve quality concerns.
· Support validation builds, first article inspections, and pilot production runs.
· Participate in quality review meetings and provide inspection data as required.
· Assist with supplier material inspections and verification activities as needed.
Continuous Improvement & Compliance
· Follow established Quality Management System procedures and work instructions at all times.
· Contribute ideas to improve inspection efficiency, documentation accuracy, and product quality.
· Maintain a clean, organized, and controlled inspection area in alignment with 5S principles.
· Perform other duties assigned by Quality leadership.
Additional Responsibilities
· Maintain production and inspection records in compliance with regulatory and internal retention requirements.
· Review and approve quality-related documentation, including specifications, work instructions, engineering changes, and validation protocols.
· Represent Quality in new product introductions, risk management activities, and lifecycle change control.
· Perform other duties as assigned by senior leadership.
Knowledge:
· Familiarity with ISO 9001 or 13485 and the US Quality System Requirements
· Proficient in using Microsoft Office Suite: Word, Excel, Power-Point.
· Familiar with creating and editing in Adobe.
· Lot generation, First-In-First-Out (FIFO) inventory management, Kanban system methodology.
· Working knowledge of ERP systems related to inventory management, purchasing, manufacturing transactions, lot traceability, job scheduling, and material requirements planning (MRP). Microsoft Dynamics 365, Cetec ERP, or equivalent experience preferred
· Ability to analyze quality and operational data, identify trends, and prepare reports and KPI dashboards for management review.
· Familiarity with supplier quality management, incoming inspection processes, and supplier corrective actions (SCARs).
· Experience supporting internal audits, external audits, customer audits, and certification activities.
· Strong attention to detail with the ability to maintain accurate records, manage multiple priorities, and ensure compliance with established procedures.
Skills/Experience:
- Minimum 4 years of quality experience in a manufacturing environment, preferably in a regulated industry (medical device, biotech, aerospace, etc.).
- Strong verbal and written communication skills with the ability to interface effectively at all organizational levels, including executives, customers, and regulatory bodies.
- Proven ability to present quality data, findings, risk assessments, and audit results to internal and external stakeholders with clarity and authority.
- Highly organized with strong time management skills; able to manage multiple priorities and meet tight deadlines in a fast-paced environment.
- Proficient in Microsoft 365 (Word, Excel, PowerPoint, Outlook, Teams); advanced Excel or data analysis experience preferred.
- Demonstrated capability in data-driven decision making, including statistical analysis, measurement systems, and quantitative problem solving.
- Expertise in root cause analysis, CAPA, risk management, and failure investigation (product, process, or material-based).
- Ability to work both independently and cross-functionally, driving accountability without constant oversight.
- Professional presence, strong interpersonal skills, and the ability to lead with influence as well as authority.
- Bachelor’s degree in science, engineering, or business discipline preferred; relevant technical or quality system experience may substitute for formal degree.
Pay: $25.00 - $34.00 per hour
Benefits:
- 401(k) matching
- AD&D insurance
- Dental insurance
- Disability insurance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Work Location: In person
