Job Title: Quality Assurance Manager – Medical Device Manufacturing
Location: Lindon, UT
Company Overview
BirdieRP is an ISO 13485–certified medical device manufacturer specializing in precision injection molding and assembly of Class I and II medical products. We are committed to quality, compliance, and continuous improvement in every aspect of our operations.
Position Summary
- The Quality Assurance (QA) Manager is responsible for leading the company’s quality management system (QMS) in compliance with ISO 13485 and FDA 21 CFR Part 820 requirements. This role ensures that all manufacturing, assembly, and inspection activities meet applicable regulatory, customer, and internal standards. The ideal candidate will be a proactive leader experienced in risk-based decision making, supplier quality management, and audit readiness.
Key Responsibilities
- Lead and maintain the QMS in accordance with ISO 13485 and FDA Quality System Regulation (QSR) requirements.
- Oversee quality assurance activities across injection molding, component assembly, packaging, and finished device processes.
- Manage internal, supplier, and customer audit programs, ensuring effective corrective and preventive actions (CAPA).
- Serve as the primary point of contact during FDA inspections, Notified Body audits, and customer quality assessments.
- Implement and maintain risk management programs per ISO 14971, applying risk-based thinking across all quality operations.
- Oversee document control, nonconforming product reviews, and complaint handling.
- Collaborate with engineering and production teams to develop validation protocols (IQ/OQ/PQ) and process improvements.
- Support training programs to promote quality awareness and regulatory compliance throughout the organization.
- Lead management review meetings and quality performance metrics reporting.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related field (advanced degree preferred).
- Minimum of 7 years of experience in medical device manufacturing, with at least 3 years in a leadership or management role.
- Demonstrated expertise with ISO 13485, FDA QSR (21 CFR 820), and risk management principles under ISO 14971.
- Hands-on experience with injection molding, assembly operations, and quality inspection techniques.
- Proven success managing internal and external audits, as well as direct interactions with FDA or other regulatory bodies.
- Strong analytical skills and proficiency with root cause analysis, CAPA, and process validation tools.
- Excellent communication, leadership, and cross-functional collaboration skills.
Preferred
- Experience with statistical process control (SPC) and quality engineering tools.
- Working knowledge of EU MDR and international regulatory requirements.
- Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) credential.