Quality Assurance Inspector I

Integra LifeSciences Corporation; Montana; Sur place; USD 23 000 - 30 000; Plein temps

Avantages offerts par ce poste

401(k) savings plan

Health benefits

Résumé du poste

Integra LifeSciences is seeking a Quality Inspector in Montana to perform incoming, in-process, and finished goods inspections, verify labels and packaging, and review Lot History Records to ensure compliance with ISO 13485, GMP, and FDA requirements.

You will document nonconformities, support CAPAs with root cause analysis, maintain GDP-compliant records, and collaborate with Quality Engineers and Production to resolve issues.

Qualifications

• Experience applying inspection techniques and measuring tools in regulated manufacturing.
• Ability to read and interpret technical drawings, specifications, and work instructions.
• Excellent documentation skills and attention to detail in GMP/ISO contexts.
• Proficiency with electronic quality management systems (eQMS) and MS Office.

Responsabilités

• Conduct incoming inspections of raw materials and components to verify specifications.
• Perform in-process inspections to ensure assemblies meet quality standards and regulatory requirements.
• Inspect finished goods returning from sterilization for release criteria compliance.
• Verify labels and packaging meet regulatory and product requirements.
• Review Lot History Records to ensure assembly instructions are followed.

Connaissances

Inspection techniques

Drawing interpretation

Documentation

eQMS proficiency

MS Office

Cross-functional collaboration

Description du poste

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.

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 [e-mail].

Whatever your specialty, you'll find an ideal setting for building a rewarding career.

Along the way, you'll have the satisfaction of knowing your work matters, that it's making patients' lives better, making a positive and lasting difference. You'll find that the pace is exhilarating - because the need is so urgent. You'll be challenged - and supported - by the most dynamic and inspiring people in your profession. And you'll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we're a great place to build a career. Here's your chance to discover that for yourself.