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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.
SUMMARY
The Sr. Quality Inspector is responsible for supporting Quality Control Incoming Inspection and Review & Release activities to ensure compliance with internal procedures, regulatory requirements, and quality standards. This position serves as a key technical resource within the Quality Control organization, providing support for incoming material inspection, batch record review, product release activities, non-conformance investigations, and continuous improvement initiatives.
The role works collaboratively with Manufacturing, Engineering, Quality Assurance, Supply Chain, and other cross-functional groups to support daily operations and maintain operational efficiency. This position is expected to operate flexibly between QC Incoming Inspection and Review & Release functions based on business needs, workload demands, and organizational priorities while ensuring compliance and product quality. Perform the essential duties and responsibilities listed in section below.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Primary responsibilities are to:
- Supports QC collaboration with Quality Management to ensure all quality standards are met, including but not limited to inspecting reports are properly updated and completed in a timely manner.
- Inspects products, processes, and systems to ensure compliance with quality standards.
- Assists in investigating non-conformances, identifying root causes, and implementing corrective actions.
- Supports documentation and reporting quality control findings and the analysis of data to recommend process improvements.
- Supports Review & Release activities including review of manufacturing, inspection, and quality records to ensure completeness, accuracy, and compliance with established procedures.
- Supports Inspection and testing raw materials, intermediates and record test results. Assist as needed in test method validation, implementation, and execution.
- Assists in training employees in quality standards, KPIs and procedures.
- Assists with the implementation of new or improved quality control systems as needed.
- Supports maintaining a working inventory of all department components, materials and solutions.
- Ability to assist in root cause analysis and implement corrective actions.
- Serves as an informal resource for colleagues with less experience.
- Collaborate with Quality Management to ensure compliance with industry regulations, company policies, and safety standards during the transition process.
- Provides database support with generating reports and analyzing process data.
- Support Quality Management in preparing for and participating in FDA audits, customer audits, etc.
- Maintains work areas and equipment in a clean and orderly condition.
- Must be able to work in a Team environment, multi-task and communicate effectively.
- Demonstrate excellent organizational and time management skills.
- Knowledge of industry standards and regulations related to quality control.
- Perform other duties as required.
DESIRED MINIMUM QUALIFICATIONS
High school diploma or equivalent with 5 years of experience; A bachelor’s degree or associate degree in a related field is preferred.
Related work experience is preferred in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other regulated industry.
Familiarity with application of FDA and/or ISO quality standards in a government regulated industry.
Moderate computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.
Knowledge of QC terms, tools, and methodologies.
Working knowledge of standard laboratory practices and safety.
Ability to follow instructions precisely, recognize deviations, and recommend corrective action.
Detail-oriented.
TOOLS AND EQUIPMENT USED
Calipers, rulers, dataloggers, standard office equipment (i.e. computers, phones, photocopiers, filing cabinets, other general office equipment).
Salary Pay Range:
$23.28 - $31.46 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
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 | EOE including Disability/Protected Veterans
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. 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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