Quality Inspector I

Enerpac Tool Group Corp•Munsons Corners, NY

4d•Onsite

About The Position

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.

Requirements

High school diploma or equivalence
Microsoft Windows experience with Word and Excel
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

Nice To Haves

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)
Associate’s degree (Preferred)

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.