Quality Assurance Inspector I

Integra LifeSciences; West Valley (WA); On-site; USD 35,000 - 46,000; Full time

Job summary

Integra LifeSciences is seeking a Quality Inspector to perform incoming, in-process, and final inspections in a regulated medical device environment. You will verify materials, assemblies, labels, and packaging against specifications, maintain GDP-compliant records, and support root-cause analysis and continuous improvement.

The ideal candidate has 1–5 years of experience, familiarity with ISO 13485, FDA 21 CFR 820, GMP, and strong attention to detail.

Qualifications

• 1–5 years of quality inspection or equivalent in medical device or regulated manufacturing.
• Familiarity with ISO 13485, FDA 21 CFR 820, and GMP preferred.
• Able to interpret drawings and work instructions; strong attention to detail and documentation.

Responsibilities

• Conduct incoming inspections of raw materials and components.
• Perform in-process inspections to ensure assemblies meet standards.
• Inspect finished goods returning from sterilization.
• Verify labels and packaging for accuracy and regulatory compliance.
• Review Lot History Records to ensure correct assembly instructions.
• Document nonconformities via NCMR process.
• Collaborate with Quality Engineers and Production to resolve issues.
• Maintain GDP-compliant inspection records.
• Support continuous improvement and root cause analyses.
• Maintain a clean, safe working environment.
• Perform other related duties as required.

Skills

Inspection techniques

Technical drawings interpretation

Documentation skills

MS Office & eQMS

Cross-department collaboration

Education

ISO 13485 familiarity

FDA 21 CFR 820 familiarity

GMP familiarity

Tools

eQMS

Measurement tools

Microsoft Office

Job description

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Key Responsibilities

To perform this job successfully, an individual must be able to execute the following responsibilities satisfactorily:

• Conduct incoming inspections of raw materials and components to verify compliance with specifications.
• Perform in-process inspections to ensure assemblies meet quality and regulatory standards.
• Inspect finished goods returning from sterilization to ensure compliance with final release criteria.
• Verify labels and packaging for accuracy and compliance with regulatory requirements.
• Ensure assembly instructions are properly followed by reviewing Lot History Records.
• Identify and document nonconformities through the Nonconforming Material Reports (NCMR) process.
• Work collaboratively with Quality Engineers and Production teams to resolve quality issues.
• Maintain complete and accurate inspection records in compliance with Good Documentation Practices (GDP).
• Support continuous improvement initiatives and participate in root cause analysis and corrective actions.
• Maintain a clean and safe working environment in accordance with company policies.
• Perform other related duties as required.

Desired Minimum Qualifications

Education & Experience

• 1 – 5 years of experience in quality inspection or a similar role within the medical device, pharmaceutical, or regulated manufacturing industry.
• Equivalent combination of education and experience will be considered.
• Familiarity with ISO 13485, FDA 21 CFR 820, and Good Manufacturing Practices (GMP) is preferred.

Skills & Competencies

• Strong knowledge of inspection techniques, measurement tools, and quality control methods.
• Ability to interpret technical drawings, specifications, and work instructions.
• Excellent attention to detail and documentation skills.
• Proficiency in Microsoft Office (Excel, Word, Outlook) and ability to use electronic quality management systems (eQMS).
• Effective communication and collaboration skills to work across departments.

Salary Pay Range:

$16.68 – $22.12 USD Hourly

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training . In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences (https://www.integralife.com/careers/total-rewards)

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].