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 Control Inspector will be responsible for supporting all activities performed within the Quality Control Inspection team. This role also involves supporting non-conformance investigations, identifying root causes, and contributing to the continuous improvement of processes. Works collaboratively with Manufacturing, Engineering, Quality Assurance, and other functional experts to support all daily operational activities. Consults with management to resolve quality, production, and efficiency problems. Functions in conjunction with the Quality Control Inspection Supervisor and functional experts on special department projects.ESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily.Primary responsibilities are to:
Ensure all quality documentation is properly updated and completed in timely manner.
Collaborate with Quality Management to ensure all quality standards are met.
Conduct inspections of products, processes, and systems to ensure compliance with quality standards.
Assist in investigating non-conformances, identifying root causes, and implementing corrective actions.
Document and report quality control findings and support the analysis of data to recommend process improvements.
Ensure all quality documentation is properly updated and completed in timely manner.
Assist in training employees on quality standards, KPIs and procedures.
Support the implementation of new or improved quality control systems as needed.
Ensure compliance with industry regulations, company policies, and safety standards during the transition process.
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.
Inspection and testing of raw materials, intermediates and recording of test results.
Assists in maintaining a working inventory of all department components, materials and solutions.
Assist as needed in test method validation, implementation, and execution.
Provides database support, generate reports and analyze process data.
Assist in preparing for and participating in FDA audits, customer audits, etc.
Demonstrate excellent organizational and time management skills.
Knowledge of industry standards and regulations related to quality control.
Ability to assist in root cause analysis and implement corrective actions
Perform other duties as required.
DESIRED MINIMUM QUALIFICATIONS
High School Diploma or equivalent with 10+ years of experience required, bachelor's degree or associate's degree preferred
5 years related work experience is required 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 USEDCalipers, rulers, dataloggers, standard office equipment (i.e. computers, phones, photocopiers, filing cabinets, other general office equipment).PHYSICAL REQUIREMENTSThe physical requirements listed in this section include but are not limited to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak and have the ability to move throughout all locations of the building. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.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/adaveteransemployers.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)
