Quality Control Technician Medical Device

Job Description

Job Description

Benefits:

• 401(k)
• Competitive salary
• Dental insurance
• Flexible schedule

Job Title: Quality Assurance Technician (V&V / NPI)

Role Summary The Quality Assurance Technician plays a key role in maintaining product standards, focusing primarily on New Product Introduction (NPI) and Verification & Validation (V&V) activities. Collaborating closely with Quality Engineering, Manufacturing, and R&D teams, this position ensures all deliverables adhere to design specifications, industry regulations, and internal quality metrics across the entire product lifecycle.

Primary Responsibilities

V&V and NPI Operations

• Perform functional, performance, and durability test protocols according to approved methods.

• Configure testing hardware, custom fixtures, and sample units as specified in standard operating procedures.

• Document, process, and summarize test metrics following Good Documentation Practices (GDP).

• Log, report, and escalate test deviations or out-of-specification findings promptly.

• Participate in root cause evaluations and failure investigations.

• Work alongside R&D engineers to assemble prototypes, perform design iterations, and support early-stage build runs.

• Offer practical insights regarding quality concerns, testing feasibility, and design manufacturability.

Compliance & Continuous Improvement

• Conduct all testing operations in alignment with ISO 13485, FDA guidelines, and internal quality policies.

• Draft, organize, and archive complete test logs, technical reports, and trace records.

• Support document management by drafting revisions for test procedures, work instructions, and inspection standards.

• Tackle special projects and cross-functional quality tasks as assigned.

Qualifications

• Education & Background: Associate degree in an engineering, technical, or scientific discipline, or an equivalent mix of education and hands-on experience.

• Experience: Minimum of 2 years in quality assurance, product testing, or manufacturing operations (medical device industry strongly preferred).

• Regulatory Knowledge: Solid understanding of quality system regulations, specifically ISO 13485 or FDA 21 CFR Part 820.

• Technical Skills: Experience conducting test protocols, utilizing laboratory measurement tools, and working with basic data analysis tools (e.g., MS Excel).

• Quality & Detail Focus: Strong analytical mindset with rigorous attention to detail and record-keeping; ability to interpret technical drawings and schematics.

• Collaboration: Excellent interpersonal communication and cross-functional team skills.

• Bonus: Exposure to electronic Quality Management Systems (eQMS) software.

Working Conditions

• Split between laboratory testing environments, production floor areas, and standard office spaces.

• Requires occasional lifting, extended periods of standing, and direct operation of test equipment.