Quality Inspector I

CORTLAND – Who we are? Enerpac Tool Group Corp. is a premier industrial tools, services, technology, and solutions provider serving a broad range of customers with high‑performance biomedical textile structures. The company applies over 40 years of experience in textile engineering and advanced fabric design methods to produce braided, knitted and woven products that meet the demands of a diverse set of customers in the biomedical product space. Complex biomedical textile challenges are tackled with agility, credibility and curiosity. Summary – Basic Function Of The Role The Quality Technician is integral to the success of our growing medical business. The position will have responsibility within all phases of medical device inspection and test, including final documentation review and product release. The Technician will assist in‑house Cleanroom Environmental Bioburden Monitoring and Particulate Monitoring, as well as the associated biocompatibility Laboratory Testing and data analysis. Act as a Voice of Customer; uphold all quality policy and procedure in support of the Medical Device ISO 13485 Quality Management System requirements. The individual will take an active role and support the Safety Management System practiced at Cortland, NY. Work Schedule Monday – Friday; 7:00 am – 3:30 pm or 7:30 am – 4:00 pm; flexible Location In‑office Monday – Friday 850 Lime Hollow Rd. Cortland, NY 13045 Salary Range $17.03 – $25.55 per hour $1,500 sign‑on bonus Job Duties And Responsibilities Support the supply chain and manufacturing by performing Receiving Inspection and Test, In‑Process Inspection and Test, and Final Inspection and Test. Conduct final documentation review, packaging and label review and generate the Certificate of Analysis and/or Certificate of Acceptance in support of final product approval and QA release for delivery. Conduct verification and validation inspection and test as required. Participate in TMV/MSA (GRR) studies as required. Support the in‑house Cleanroom environmental bioburden monitoring and particulate monitoring and proactive data analysis. Identify statistical changes in the data performance and identify opportunities for improvement. Support the biocompatibility laboratory testing and proactive data analysis. Identify statistical changes in the data performance and identify opportunities for improvement. Support monitoring the in‑house ultra‑pure water system for cleanliness in terms of endotoxin and microbial performance. Support organizational growth within the area of Analytical Chemistry and the associated testing requirements and activity. Act as a Voice of Customer; uphold all quality policy and procedure in support of the ISO 13485 Quality Management System requirements. Escalate concerns in a timely manner. Schedule and conduct Internal Quality Audits as assigned. Generate the audit reports, review the report with applicable management and ensure that non‑conformance is processed within the Internal Quality Audit system. Actively participate in continuous improvement events as required. Actively participate in the NCR system as required. Actively participate in the CAPA system as required. Participate in and uphold all safety policies and procedures. Skills And Competencies Experience in an ISO 9001:2008 and/or ISO 13485:2003 (Preferred) Experience in QMS Internal Auditing (Preferred) Experience in textile manufacturing and/or medical device manufacturing (Preferred) Background or experience in Biology and / or Life Sciences (Preferred) To always ensure that their acts or omissions do not present a danger to themselves, anyone else, the Environment or the safe operation of any plant or equipment. To intervene and report any defect in equipment or practice or any dangerous circumstance or event which could affect HSSEQ performance. To comply with all HSSEQ requirements imposed by clients on their sites. To actively propose and implement improvements to HSSEQ systems. To cooperate with the company in achieving HSSEQ objectives. To participate fully in Continuous Improvement activities where necessary & when required. Education And Experience High school diploma or equivalence Microsoft Windows experience with Word and Excel Associate’s degree (Preferred) Physical Demands Employee may have to lift documents/work materials up to 50 pounds. Employee must be able to walk/climb to a variety of primary work locations, including occasional ascending or descending ladders, stairs, scaffolding, ramps, poles, and the like. Employee may move themselves in different positions to accomplish tasks in various environments including tight and confined spaces. Employee will need to move about to accomplish tasks or move from one worksite to another. Employee will need to operate machinery and/or power tools, motor vehicles, and heavy equipment. Employee must listen, understand, and speak with team members in person, telephonically, and electronically at all levels within a diverse workforce and with supported organizations. Employee must assess the accuracy, neatness, and thoroughness of the work assigned. Employee will remain in a stationary position, often standing or sitting for prolonged periods. Employee will use repeating motions that may include the wrists, hands, and/or fingers. This will also include eye focus and fine finger dexterity required for threading high counts and small sizes of yarn into machines. Work Environment Primary work environment is a controlled manufacturing space with specific gowning and PPE requirements. Proper demonstration of correct execution of these gowning and PPE requirements is required. Stretching may be required periodically as part of the job. These physical demands and work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Direct Reports None Key External Contacts/Clients Biomedical Fabricators and Operators Engineers: Quality, Development, Manufacturing EEO Statement Enerpac is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected status in accordance with applicable federal, state, and local laws. We are committed to creating an inclusive environment for all employees and applicants and encourage candidates of all backgrounds to apply. If you are an individual with a disability and you need assistance or a reasonable accommodation during the application process, please reach out to us at View email address on click.appcast.io. #J-18808-Ljbffr