Quality Control Inspector

About the Role

We're looking for a temporary Quality Control Inspector to join our mission-driven Quality team. In this role, you'll be responsible for performing inspections of components, subassemblies, and finished medical devices to ensure compliance with quality standards and regulatory requirements. This includes conducting quality checks, performance tests, reviewing documentation, and verifying Device History Records (DHR) for product release in accordance with the medical device Quality Management System (QMS).

Responsibilities

• Perform audits, inspections, configuration checks, and functional testing to ensure product quality and compliance with established procedures.
• Review and verify lot history records for completeness, accuracy, and adherence to SOPs; investigate records tied to customer experience reports.
• Inspect subassemblies, finished products, purchased components, and tools using defined criteria and standard measurement techniques.
• Conduct product rework on subassemblies or finished goods as needed.
• Accurately document inspection and testing results in accordance with Good Documentation Practices (GDP).
• Review Device History Records (DHR) for compliance with established procedures and GDP requirements.
• Identify quality issues and provide well-reasoned recommendations for corrective actions or process improvements.
• Perform product testing to confirm conformance to quality standards, escalating issues promptly when expectations are not met.
• Work within a cleanroom environment, strictly following protocols and safety requirements.
• Perform environmental monitoring and manage ERP (QAD) and MES transactions.
• Support continuous improvement efforts by partnering with Manufacturing, Engineering, and Quality teams.
• Take on additional responsibilities as needed, demonstrating adaptability and accountability.

Qualifications

• High School Diploma or equivalent required.
• 1–5 years of Quality Control experience, preferably in the medical device industry.
• Ability to understand and follow technical procedures, work instructions, and basic specifications related to inspection of products and components.
• Skill in identifying relevant information in technical drawings and documents and reporting discrepancies to the supervisor.
• Familiarity with applicable quality standards and willingness to learn about specific regulations under supervision.
• Mechanical aptitude and working knowledge of measurement instruments.
• Strong written and verbal communication skills for reports, correspondence, and presentations.
• Mathematical proficiency in fractions, percentages, ratios, and proportions.
• Problem-solving skills with the ability to work in a cross-functional environment and manage multiple priorities.