Quality Assurance Associate
Quality Assurance Associate
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Salary Not Disclosed
1 Vacancy
Job Description
What makes you great:
- Bachelors/Associates Degree in a Science/ Engineering or related technical field
- Background in quality medical products preferred
- Knowledge in the FDAs regulations for medical products 21 CFR part 210 and 211
- Strong communication skills & organizational agility
- Solid organizational skills
- Strong knowledge of Microsoft Office Applications and Lotus Notes database skillsets
- Basic of HTML and JavaScript computer language preferred
- ISO 9001 or ISO 13485 and or regulatory experience
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 and protect our planet.
The company serves a variety of end markets including chemicals & refining food & beverage electronics healthcare manufacturing and primary metals. Lindes industrial gases are used in countless applications from lifesaving oxygen for hospitals to highpurity & specialty gases for electronics manufacturing hydrogen for clean fuels and much more. Linde also delivers stateoftheart gas processing solutions to support customer expansion efficiency improvements and emissions reductions. For more information about the company please visit our website atwww.lindeus.
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 Associate
Quality Assurance Specialist will be responsible for reviewing and ensuring all steps in the manufacturing testing storage and distribution process for medical products performed in accordance with FDAs applicable regulations and LINDEs standard operating procedures. The Quality Assurance Associate will handle the quality oversight and auditing of production and incoming inspection activities review of change requests and investigation of nonconformances and out of specification reports. 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 pay
- Comprehensive benefit 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:
- Reviews all steps performed and ensures that the step in the manufacturing process has taken place as defined in the Batch Production Record.
- Reports findings of inprocess errors and provides followup to ensure adequate completion of corrective actions.
- Performs and coordinates quality investigations with appropriate levels of corrective/preventive actions and closes in a timely manner.
- Supports product quality complaint investigations assisting in data processing of Adverse Events and appropriate reporting for U.S. and Canada complaints. Supports the receipt/review of product complaint samples. Participates in the investigation and resolution of nonconformances of all types.
- Quality review of System Preventative Maintenance activities.
- Support initiatives in Continuous Quality Improvement.
- Provides training in GMP and quality principles to personnel in all departments when assigned. Assists in maintenance of training schedules and training records systems.
- Assists in the review and approval of Change Controls.
- Assists in internal and supplier audits and establishing/updating supplier and component specifications and testing as needed.
- Assists with tracking and trending of deviations and complaints.
- Follows all safety rules/regulations and immediately reports infractions and/or workplace injuries/accidents to proper personnel.
- Ensures for product disposition e.g. approvals for release distribution or rejection.
- Ensures labels are appropriately reviewed and approved for use and meet all internal and external requirements
- Other duties as assigned
Required Experience:
IC
Employment Type
Full-Time
