Quality Assurance Specialist
Quality Assurance Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
What makes you great:
- Educated to a good standard preferably a degree in a technical discipline
- Experience of working with Medical Devices knowledge of Medical device regulations including ISO 13485 and FDA 21CFR 820
- Ideally trained or experienced in internal auditing techniques
- Good attention to detail and an awareness of quality control
- Demonstrate an understanding technical information practical technical ability an advantage
- Ability to prioritize workload a good communicator and team worker
- Able to work to procedures
- Competent computer skills including
Why you will enjoy working with us:
Linde is a leading global industrial gases and engineering company with 2024 sales of $33 billion. We live our mission of making our world more productive every day by providing highquality solutions technologies and services which are making our customers more successful and helping to sustain decarbonize and protect our planet.
Linde Gas & Equipment Inc. (LG&E) is part of the largest Welding Industrial Medical and Specialty Gases companies in the U.S. We carry a comprehensive selection of industrial gases such as oxygen nitrogen argon and carbon dioxide etc. LG&E has an extensive network of production plants retail stores distribution centers and customer service locations with a focus on making our world more productive every day by providing highquality solutions technologies and services which are making our customers more successful by helping to sustain and protect our planet.
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All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age disability protected veteran status pregnancy sexual orientation gender identity or expression or any other reason prohibited by applicable law.
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Linde Gas & Equipment Inc.
Quality Assurance Specialist
Location: Livingston TN
Linde Gas & Equipment Inc. is seeking a Quality Assurance Specialist to join our team!
This role will be responsible for supporting the Livingston TN Service Center in all aspects of product repair maintenance and release of Medical Devices performed in accordance with FDAs applicable regulations and applicable standard operating procedures (e.g. 21 CFR Part 820 ISO 13485 and the local QMS). The Quality Assurance Associate will handle the Quality inspection of Device repair records complaints investigations and nonconformances trend analysis and reporting. The Quality Assurance Associate will have the ability to work independently and to provide consultative advice within specific areas of expertise.
What we offer you!
- Competitive compensation
- Comprehensive benefits plan (medical dental vision and more)
- 401(k) retirement savings plan
- Paid time off (vacation holidays PTO)
- Employee discount programs
- Career growth opportunities
What you will be doing:
- Perform quality control reviews of service and repair checklists ensuring all serviced/ repaired units are confirmed as meeting specification. Resolve any documentation issues and perform QC approval of devices to be returned to stock.
- Raise any quality or technical concerns with facility management and the LG&E national quality department to ensure they are resolved in a prompt manner.
- Ensuring procedures relating to service and repair are followed and maintained ensure control of quarantine and reject items.
- Monitoring of devices returned for repair/service for possible complaints and supporting the LG&E national quality with the investigation of potential complaints.
- Generate calibration certificates/ release certificates following device repairs.
- Author maintain and ensure compliance to technical documentation such as work instructions forms/records logbooks etc.
- Train facility personnel on Quality Management Procedures and quality principles. Assists in maintenance of training schedules and training records systems.
- Participate in the completion of Change Controls.
- Assists in internal and supplier audits and establishing/updating supplier and component specifications and testing as needed. Participate in and support external audits conducted by regulatory bodies and registrars.
- Assist with the investigation and documentation of nonconformances deviations and CAPAs (Corrective and Preventive Actions) ensuring timely and effective resolution.
- Maintain safe working practices around gas and gas products. Adhere to all Health and Safety guidelines appropriate to the role and maintain a safe working environment.
- Other duties as assigned
Required Experience:
Unclear Seniority
Employment Type
Full-Time
