Quality Engineer 2, Product Quality Assurance jobs in United States
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Teleflex · 2 weeks ago

Quality Engineer 2, Product Quality Assurance

Teleflex Incorporated is a global provider of medical technologies focused on improving health and quality of life. The Quality Engineer 2 will support the Product Quality Assurance team by analyzing post-market data and addressing potential product quality issues for commercialized devices.

CommercialHealth CareMedicalMedical Device
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H1B Sponsor Likelynote

Responsibilities

Create, investigate and/or manage nonconformances, as well as associated ship holds and product disposition
Investigate, compile and report on information necessary for executive management to assess if field actions/corrections and removals associated with Teleflex products is warranted
Work closely with Manufacturing sites, R&D, Suppliers, Supplier Quality, Marketing, Design Assurance, and Regulatory to investigate and document quality issues
Assist with compilation and analysis of product quality metrics for presentation to Global and business unit leadership
Utilize statistical techniques to identify rates, changes in trends or estimated occurrences based on bench and field data
Utilize sound technical writing to provide clear and concise written internal reports and support external communications as needed to respond to Product Quality issues
Assist during regulatory inspections and/or audits and present as required
Utilize SAP, Agile and other systems as warranted for data input and quality record maintenance
Communicate and escalate Quality issues appropriately to QA Manager and address other items as assigned by Manager

Qualification

Quality AssuranceRisk ManagementStatistical AnalysisMinitabSAPMicrosoft ExcelTechnical WritingProblem SolvingCommunicationTeam Collaboration

Required

BS Degree in Engineering (or related technical field)
2-5 years related (medical device preferred) experience
Experience with statistical analysis using Minitab and/or Microsoft Excel
Quality Assurance (21CFR820, ISO13485) and Risk Management (ISO 14971) experience required
Experience with Corrective Action and Nonconformance process
Computer literate (i.e., statistical software and analysis, excel, word processing for report generation, PowerPoint presentations, etc.)
Positive attitude and ability to operate and communicate effectively with multiple teams & leadership
Ability to reason, support and prioritize projects, adapt to shifting priorities, effectively solve problems / conflicts, and proactively effect change

Preferred

Quality Assurance (21CFR820, ISO13485) and Risk Management (ISO 14971) experience desired
Experience with Corrective Action, Manufacturing and Design Control concepts desired

Benefits

Medical, prescription drug, dental and vision insurance
Flexible spending accounts
Participation in 401(k) savings plan
Various paid time off benefits, such as PTO, short- and long-term disability and parental leave

Company

Teleflex

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Teleflex is a manufacturing company that designs and develops medical devices for the healthcare sector.

H1B Sponsorship

Teleflex has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (2)
2023 (3)
2022 (2)
2021 (4)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$400M
2016-05-12Post Ipo Debt· $400M
1990-01-01IPO

Leadership Team

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Liam Kelly
Chairman, President and CEO
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Cameron Hicks
Corporate Vice President and Chief Human Resources Officer
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Company data provided by crunchbase