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Teleflex · 3 days ago
Quality Engineer II
Chelmsford, MA
Full-time
Onsite
Mid Level
2+ years exp
Wonder how qualified you are to the job?
Maximize your interview chancesCommercialHealth Care
Hiring Manager
Lexy Cianfrani
Insider Connection @Teleflex
Responsibilities
Nonconformance (NC) and CAPA processing – lead quality activities such as inspection methods, NC containment, correction, closure and CAPAs; and drive improvement through analysis of trend data.
Support Incoming & In-Process Inspection teams.
Support the value stream with investigations required for field corrective actions including risk evaluation.
Participate in internal audit activities and support supplier corrective actions as needed. Participate in vendor audits if necessary. Support the Back Room during regulatory and notified body audits.
Production & Process Controls – review, change and approve manufacturing procedures; test method validations; Quality Inspection plans and process run sheets.
Documentation Control – perform change controls (ADC/ECR/ECOs) as needed.
Training – Perform QA training certifications on new production operators as needed.
Support Engineering with new product development with quality planning, risk evaluation, and validation.
Perform any additional QA tasks, as assigned by QA Manager.
Maintain compliance with Teleflex Global & local procedures and policies.
This position requires direct contact with an implantable device. ☐ Yes ☒ No
Qualification
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Required
Minimum 4-year degree in an engineering discipline – Mechanical, Biomedical, Plastics, Industrial, etc.
Minimum 2-3 years experience of quality and/or related manufacturing/engineering role, preferably in a manufacturing site.
Quality system management and deployment experience preferred.
Problem-solving and quality improvement, including quantitative methods.
Validations (product and process IQ/OQ/PQ).
Knowledgeable of ISO 13485, ISO 14971, and FDA QSR requirements.
Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required.
Good listening, verbal, and written communication skills.
Excellent interpersonal skills with a demonstrated ability to work in a team environment.
Ability to prioritize and adapt to shifting priorities.
Ability to work independently with limited supervision.
Preferred
Working knowledge and/or experience with SAP and AGILE is strongly preferred.
Company
Teleflex
Teleflex is a diversified global company, distinguished by a significant presence in healthcare, with niche businesses.
10,001+ employees
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
Trends of Total Sponsorships
2023 (2)
2022 (2)
2021 (5)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$400M2016-05-12Post Ipo Debt· $400M
1990-01-01IPO· nyse:TFX
Leadership Team
Liam Kelly
Chairman, President and CEO
Thomas Powell
EVP, Chief Financial Officer
Recent News
2024-05-05
Globe Newswire
2024-02-22
Company data provided by crunchbase
