Biomedical Quality Technician

Full Time | Cortland, NEW YORK | 11 days

Job Summary

Full Time
Cortland
Actuant

Job Description


Cortland is a global designer, manufacturer, and supplier of technologically advanced medical textiles, ropes and slings cables and strength members. Collaborating with customers, our team uses its experience in high performance materials and market knowledge to transform ideas into proven products. For more than 35 years, our custom-built solutions have been developed for work in the toughest environments and to overcome some of the world’s greatest challenges. They consistently enable our customers to meet the demands of the aerospace, defense, medical, research, subsea, marine, and energy industries.

Cortland is wholly owned by Actuant Corporation. Actuant Corporation is a diversified industrial company serving customers from operations in more than 30 countries. The Actuant businesses are leaders in a broad array of niche markets including branded hydraulic tools and solutions; specialized products and services for energy markets and highly engineered position and motion control systems. The Company was founded in 1910 and is headquartered in Menomonee Falls, Wisconsin. Actuant trades on the NYSE under the symbol ATU. For further information on Actuant and its businesses, visit the Company’s website at www.actuant.com , or visit the links below:

Our Leadership Team

Fact Sheet

LinkedIn

Job Title:  Biomedical Quality Technician

Location: Cortland, NY

Business Contribution:

Cortland Biomedical provides medical device instruments and long term medical device implant components to industry leading OEM’s for final assembly, sterilization, packaging and labeling of the finished medical device.  The Biomedical 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 lead the 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 and FDA 21 CFR PART 820 requirements.   The incumbent will be expected to take an active role in the Internal Quality Audit program (as an auditor), and participate in Cortland’s Lean manufacturing program called LEAD.   The individual will take an active role and support the Safety Management System practiced at Cortland, NY.

Key Responsibilities:

  • Support the Supply Chain and Manufacturing by performing Receiving Inspection and Test, In-Process Inspection and Test and Final Inspection and Test.
  • Conduct verification and validation inspection and test as required.
  • Conduct final documentation review, packaging and label review and generate the Certificate of Conformance and Certificate of Analysis in support of final product approval and QA release for delivery.
  • Lead the in-house Cleanroom environmental bioburden monitoring and particulate monitoring. Conduct the associated biocompatibility laboratory testing and proactive data analysis. Identify statistical changes in the data performance and identify opportunities for improvement.
  • Sample, conduct testing and monitor 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.

Key Relationships:

The Biomedical Quality Technician is an extremely cross-functional position and will be the go to person for inspection and test, Cleanroom monitoring and final product approval for release and delivery – key networking within the medical teamincludes the following contributors:

  • Quality Leader
  • Manufacturing Manager
  • Production Supervisor
  • Manufacturing Personnel
  • Design and Process Engineering
  • Quality and Validation Engineering
  • Shipping / Receiving Personnel

Required Capabilities (describe scope of knowledge and ability of the position):

  • High school diploma or equivalence (Required)
  • Microsoft Windows experience with Word and Excel (Required)
  • Associates Degree (Preferred)
  • Experience in an ISO 9001:2008 and/or ISO 13485:2003 (Preferred)
  • Experience in textile manufacturing and/or medical device manufacturing (Preferred)
  • Background or experience in Biology and / or Life Sciences (Preferred)

HSEQ Behaviors:

  • 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 HSEQ performance.
  • To comply with all HSEQ requirements imposed by clients on their sites.
  • To actively propose and implement improvements to HSEQ systems.
  • To cooperate with the company in achieving HSEQ objectives.
  • To participate fully in Continuous Improvement activities where necessary & when required

Leadership / Behaviors:

  • Drive for results
  • Detail oriented
  • Listening
  • Organizing
  • Stand alone
  • Time management

If you’re looking for a unique, exciting career with variety and potential for growth, Actuant offers challenges & extraordinary rewards for people on a global scale.  Choose opportunity – choose Actuant!

EEO/AA (W/M/Vets/Disability) Employer

*LI-JH1


Cortland, New York, United States

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