Overview

CORTLAND - Who we are?

Enerpac Tool Group Corp. is a premier industrial tools, services, technology, and solutions provider serving a broad Cortland Biomedical custom builds high-performance biomedical textile structures. The company applies over 40 years of experience in textile engineering and advanced fabric design methods to braid, knit and woven products that meet the demands of a diverse set of customers in the biomedical product space. The company also offers a full range of design, development and manufacturing services as well as a wide variety of biomedical materials. Never comfortable with the status quo, complex biomedical textile challenges are tackled with agility, credibility and curiosity.

Cortland Biomedical is wholly owned by Enerpac Tool Group. Enerpac Tool Group Corp. is a premier industrial tools, services, technology, and solutions provider serving a broad and diverse set of customers and end markets for mission-critical applications in more than 100 countries. The Company makes complex, often hazardous jobs possible safely and efficiently. Enerpac Tool Group's businesses are global leaders in high pressure hydraulic tools, controlled force products, and solutions for precise positioning of heavy loads that help customers safely and reliably tackle some of the most challenging jobs around the world. The Company was founded in 1910 and is headquartered in Milwaukee, Wisconsin. Enerpac Tool Group common stock trades on the NYSE under the symbol EPAC.

For further information on Cortland Biomedical, visit the Company's website at https: //www.cortlandbiomedical.com

For further information on Enerpac Tool Group and its businesses, visit the Company's website at https: //www.enerpactoolgroup.com

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, NY13045

Salary Range: $17.03 - $25.55

This role is not eligible for sponsorship now or in the future.

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 Certificate 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 in weight. Employee will have to be able to walk/climb to a variety of primary work locations, this can include 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 will need to listen, understand, and speak with team members in person, telephonically, and electronically at all levels within a diverse workforce and with supported organizations. Employee will need to 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 would be required. Stretching is also required periodically as part of the job.

The physical demands and work environment characteristics described here 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: recruiter@enerpac.com

If you're looking for a unique, exciting career with variety and potential for growth, Enerpac Tool Group offers challenges and rewards for people on a global scale.