Quality Inspector II, 2nd Shift - Integra LifeSciences
Plainsboro, NJ
About the Job
Changing lives. Building Careers.
Joining us is a chance for you 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, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
The Quality Inspector will be responsible for performing quality assurance inspections on purchased components, manufactured sub-assemblies and final product. The Quality Inspector will perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be familiar with and able to measure critical dimensions.
+ Perform inspection by using a variety of inspection measuring and test equipment to determine acceptance or rejection of material or parts.
+ Perform first article, incoming/receiving, and in-process inspections of materials or parts; determine acceptance or rejection after inspection and/or testing of materials, parts, and/or equipment.
+ Interpret and work within the guideline of drawings, specifications, charts, procedures, and other data to determine acceptance or rejection of materials.
+ Read and interpret sampling pan as per the American national standard institute (ANSI),
+ Assist in the review and disposition of non-conforming material and customer returned material, including rework, scrap, and return to vendor.
+ Maintain accurate and current inspection and/or testing records such as nit not limited to Material Certifications, Inspection/Test Results and reports, Certificates of Conformance, Rejection reports/tags, as required by applicable procedure and/or specification.
+ Coordinate and inform other departments of inspection and/or testing status in support of production and project goals and initiatives.
+ Promote and participate in continuous improvement initiatives.
+ Responsible for the maintenance of appropriate conditions of all quarantine locations.
+ Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures.
+ Inspection requirements include training and working in classified clean rooms as necessary to perform in process inspections.
+ Maintain records of inspection and all testing performed on the appropriate test records.
+ Perform line clearances and quality reviews in manufacturing, labeling, or other assigned areas during manufacturing activities.
+ Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs.
+ Provide quality support to various departments as needed, e.g. engineering, product development, etc.)
+ Assist in training new associates according to the Quality System Regulations and company SOPs as applicable.
+ May also perform other related duties, responsibilities, and special projects as assigned.
Qualifications:
+ Associate degree preferred.
+ 3-7 years of relevant GMP/GLP experience specific to incoming, line clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry.
+ QA experience in the medical device industry preferred.
+ Must have strong written and verbal communication skills.
+ Strong organizational skills, self-directed, strong problem solving and interpersonal skills.
+ Knowledge of CAPA, Validations, Change Control, preferred.
+ Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP.
+ Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred.
+ Ability to define problems, collect data, establish facts and draw valid conclusions.
+ Ability to work effectively in a cross functional environment
+ Ability to integrate quality objectives across multiple functions.
+ Attention to detail, strong time management are essential.
+ Must be able to work independently with minimal supervision.
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/laws/index.cfm) | 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 careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Joining us is a chance for you 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, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.
The Quality Inspector will be responsible for performing quality assurance inspections on purchased components, manufactured sub-assemblies and final product. The Quality Inspector will perform all duties in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be familiar with and able to measure critical dimensions.
+ Perform inspection by using a variety of inspection measuring and test equipment to determine acceptance or rejection of material or parts.
+ Perform first article, incoming/receiving, and in-process inspections of materials or parts; determine acceptance or rejection after inspection and/or testing of materials, parts, and/or equipment.
+ Interpret and work within the guideline of drawings, specifications, charts, procedures, and other data to determine acceptance or rejection of materials.
+ Read and interpret sampling pan as per the American national standard institute (ANSI),
+ Assist in the review and disposition of non-conforming material and customer returned material, including rework, scrap, and return to vendor.
+ Maintain accurate and current inspection and/or testing records such as nit not limited to Material Certifications, Inspection/Test Results and reports, Certificates of Conformance, Rejection reports/tags, as required by applicable procedure and/or specification.
+ Coordinate and inform other departments of inspection and/or testing status in support of production and project goals and initiatives.
+ Promote and participate in continuous improvement initiatives.
+ Responsible for the maintenance of appropriate conditions of all quarantine locations.
+ Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures.
+ Inspection requirements include training and working in classified clean rooms as necessary to perform in process inspections.
+ Maintain records of inspection and all testing performed on the appropriate test records.
+ Perform line clearances and quality reviews in manufacturing, labeling, or other assigned areas during manufacturing activities.
+ Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs.
+ Provide quality support to various departments as needed, e.g. engineering, product development, etc.)
+ Assist in training new associates according to the Quality System Regulations and company SOPs as applicable.
+ May also perform other related duties, responsibilities, and special projects as assigned.
Qualifications:
+ Associate degree preferred.
+ 3-7 years of relevant GMP/GLP experience specific to incoming, line clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry.
+ QA experience in the medical device industry preferred.
+ Must have strong written and verbal communication skills.
+ Strong organizational skills, self-directed, strong problem solving and interpersonal skills.
+ Knowledge of CAPA, Validations, Change Control, preferred.
+ Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP.
+ Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred.
+ Ability to define problems, collect data, establish facts and draw valid conclusions.
+ Ability to work effectively in a cross functional environment
+ Ability to integrate quality objectives across multiple functions.
+ Attention to detail, strong time management are essential.
+ Must be able to work independently with minimal supervision.
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/laws/index.cfm) | 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 careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Source : Integra LifeSciences