Integra LifeSciences
Join to apply for the
Lead Quality Inspector
role at
Integra LifeSciences .
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.
The
Lead Quality Inspector
serves as a Lead Associate, Quality Inspector for the Plainsboro Manufacturing Site, Collagen Manufacturing Center (CMC). The lead associate is responsible for performing and/or scheduling quality assurance inspections on purchased components, manufactured sub-assemblies, and final product. Expectations are to be familiar with and be able to measure critical dimensions as well as to train new quality inspectors and provide guidance to current quality inspectors. The Lead Associate, Quality Inspector will perform all duties in accordance with the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies.
Shift and Compensation This is for a Weekend Lead. The shift is 12 hours on Friday, Saturday and Sunday from 6:00 AM to 6:30 PM (will be compensated for 40 hours per week).
Job Responsibilities
Oversee daily activities in the QC department.
Prepare the QC Inspection schedule to ensure that all manufacturing areas are covered in order to meet production schedule.
Report any non-conformances in a timely manner.
Support NCs and CAPA investigations as required.
Assist with product flow between departments.
Interface with Manufacturing department to coordinate inspections of completed product to ensure the inspections are done in a timely manner.
Initiate and/or propose revisions to standard operating procedures involving new processes or process improvements.
Train QC Inspectors as required.
Perform inspections (incoming, in-process, first article, etc.) by using a variety of inspection measuring equipment to determine acceptance or rejection of material or parts.
Interpret and work within the guideline of drawings, specifications, charts, procedures, and other data to determine product or material acceptance.
Read and interpret sampling plan as per the American National Standard Institute (ANSI).
Oversee physical and electronic quarantine locations.
May also perform other related duties, responsibilities, and special projects as assigned.
Desired Minimum Qualifications
Minimum of 1-2 years’ experience in document and promotional materials management using electronic document management systems or with manual systems using electronic document storage.
Minimum of 1-2 years’ experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality standards preferred.
Capable of both written and verbal effective communication skills.
Proficient in the Microsoft Office suite of products.
Proficient in Oracle R12/Agile preferred.
Salary Pay Range $26.21 - $35.38 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.
Benefits 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, group legal insurance, and savings plan (401(k)).
Equal Employment Opportunity 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. 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 careers@integralife.com.
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Lead Quality Inspector
role at
Integra LifeSciences .
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.
The
Lead Quality Inspector
serves as a Lead Associate, Quality Inspector for the Plainsboro Manufacturing Site, Collagen Manufacturing Center (CMC). The lead associate is responsible for performing and/or scheduling quality assurance inspections on purchased components, manufactured sub-assemblies, and final product. Expectations are to be familiar with and be able to measure critical dimensions as well as to train new quality inspectors and provide guidance to current quality inspectors. The Lead Associate, Quality Inspector will perform all duties in accordance with the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies.
Shift and Compensation This is for a Weekend Lead. The shift is 12 hours on Friday, Saturday and Sunday from 6:00 AM to 6:30 PM (will be compensated for 40 hours per week).
Job Responsibilities
Oversee daily activities in the QC department.
Prepare the QC Inspection schedule to ensure that all manufacturing areas are covered in order to meet production schedule.
Report any non-conformances in a timely manner.
Support NCs and CAPA investigations as required.
Assist with product flow between departments.
Interface with Manufacturing department to coordinate inspections of completed product to ensure the inspections are done in a timely manner.
Initiate and/or propose revisions to standard operating procedures involving new processes or process improvements.
Train QC Inspectors as required.
Perform inspections (incoming, in-process, first article, etc.) by using a variety of inspection measuring equipment to determine acceptance or rejection of material or parts.
Interpret and work within the guideline of drawings, specifications, charts, procedures, and other data to determine product or material acceptance.
Read and interpret sampling plan as per the American National Standard Institute (ANSI).
Oversee physical and electronic quarantine locations.
May also perform other related duties, responsibilities, and special projects as assigned.
Desired Minimum Qualifications
Minimum of 1-2 years’ experience in document and promotional materials management using electronic document management systems or with manual systems using electronic document storage.
Minimum of 1-2 years’ experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO series of quality standards preferred.
Capable of both written and verbal effective communication skills.
Proficient in the Microsoft Office suite of products.
Proficient in Oracle R12/Agile preferred.
Salary Pay Range $26.21 - $35.38 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.
Benefits 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, group legal insurance, and savings plan (401(k)).
Equal Employment Opportunity 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. 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 careers@integralife.com.
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