QA Specialist

Job Description

JOB SUMMARY

The Quality Assurance Specialist drives and supports quality improvements, risk assessment, and resolution of product non-conformance, complaint and corrective/preventative action. Communicates quality issues to all functions of the business. Works with product development and manufacturing teams to ensure product quality and compliant records and drafts revisions to product documentation to improve quality.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Process and support product nonconformance reports. Review NCRs for completeness, accuracy and adherence to cGMPs. Perform risk evaluation and provide suppliers, operations and engineering with immediate feedback regarding quality issues. Perform root cause analysis for high risk or systemic issues

Initiate Corrective and Preventative Actions. Perform risk assessment and lead investigations with a cross functional team including engineering, manufacturing, and suppliers. Draft Corrective and Preventative Actions plans. Draft Effectiveness Check Plans using statistically based rationale

Review change controls for accuracy, completeness and adherence to application regulations. Draft and implement change controls to maintain regulatory compliance, implement process improvements, and realize cost efficiencies. Draft revisions to product specifications, work instructions, and inspection documents

Oversight of equipment calibration, periodic verification, and preventative maintenance. Schedule calibrations through approved vendors. Review and approve calibration reports. Perform periodic verification per approved work instructions. Maintain calibration log and records, ensuring all equipment is serviced on time and meets cGMP requirements. Initiate non-conformance reports for defective equipment and fixtures. Coordinate repairs of faulty measuring equipment

Review repair reports and perform risk assessments for returned product. Determine and document if the repair requires a Device Complaint

Respond to customer concerns through the review, investigation and processing of complaints and repair reports; address product and process issues following internal or external review within the framework of Corrective and Preventive Actions (CAPAs) or Audit Findings (AFs)

Support compliance with applicable standards such as ISO and IEC, and domestic and international medical device regulations internationally

Monitor and identify opportunities for improvement within the quality inspection department

Participate in internal and supplier quality audits. Assist with customer audits and regulatory inspections

Maintain cGMP records, including filing, archiving, and removal per record retention policy

QUALIFICATIONS:

Education and Experience

Required

Minimum of associate degree in a technical discipline or equivalent experience

Experience in a manufacturing or quality environment

Preferred

Bachelor degree

Electronics manufacturing in an FDA regulated environment preferred

Experience using Lean Manufacturing principles

Skills and Abilities

Required

Attention to detail and accuracy

Excellent interpersonal and communication skills

Must be self-directed, self-motivated and able to work in a cross-functional team environment

Ability to exercise independent judgment and discretion on matters of significance while understanding which issues to raise and provide recommendations for resolution to higher levels of management

Optimistic outlook, team-oriented attitude

Proficient using Microsoft Word, Excel and Outlook

Proficiency in writing technical documents and production instructions

Able to interpret and understand mechanical and electrical (Gerber) drawings

Preferred

Familiarity with magnetic resonance or RF technology

Familiarity with FDA and EU medical device regulations, ISO, IEC, IPC standards

Six Sigma certification

Process Validation experience

Agile PLM/Quality module experience

1st Shift

Full-time