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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.

The **Quality Assurance Inspector I** is responsible for performing in-process and final inspections to ensure compliance with established quality standards and regulatory requirements. This role supports the development, implementation, and monitoring of quality programs to ensure that medical devices are manufactured and distributed in compliance with ISO 13485, FDA regulations (21 CFR 820), and other applicable industry standards. This position requires a strong attention to detail, the ability to work independently with minimal supervision, and effective collaboration with production, engineering, and quality teams.

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 **nonconformity** 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 (Preferred)

+ 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 https://jobs.integralife.com/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.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada\_veterans\_employers.cfm)

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 [email protected].

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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