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Company

Original Job Post

Teleflex · 6 days ago

Senior Quality Engineer

Chelmsford, MA

Full-time

Onsite

Senior Level

3+ years exp

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CommercialHealth Care

H1B Sponsorship

Hiring Manager

Lexy Cianfrani

Insider Connection @Teleflex

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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.

Prepare QSRB and QMR slides as needed.

Support the Value stream with investigations required for field corrective actions including risk evaluation.

Perform internal audits and support supplier corrective actions as needed.

Quality & Cost Improvement Projects – lead and participate in key short-term projects on product or process improvements;

Production & Process Controls – review, change and approve manufacturing procedures; test method validations; Quality Inspection plans and Process run sheets.

Auditing – routinely perform internal and process-related audits. Participate in vendor audits if necessary. Support the Back Room during regulatory and notified body audits.

Documentation Control – perform change controls (ADC/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 or Plant Manager.

Maintain compliance with Teleflex Global & local procedures and policies.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

ISO CAPAQuality System managementRisk managementDesign ControlsValidationsSupplier Quality EngineeringMedical Device Complaint HandlingProblem-solvingASQ Certified Quality EngineerCertified Quality AuditorMDSAPSupplier AuditsInternal AuditsCalibrationQAIncoming InspectionFDA QSR requirementsComputer skillsMicrosoft WordExcelPowerPointSAPAGILEListeningVerbal communicationWritten communicationInterpersonal skills

Required

Minimum 4-year degree in an Engineering discipline – Mechanical, Biomedical, Plastics, Industrial, etc.

3-5 years of experience of Quality and/or related Manufacturing/Engineering experience in a manufacturing site

CAPA, Nonconformance and MRB lead or management role

Planning, controlling and assuring product and process quality

ISO 13485 regulation knowledge and experience with MDSAP

Medical Device Complaint Handling

Quality System management and deployment experience

Risk management

Problem-solving and quality improvement, including quantitative methods

Design Controls

Validations (product and process IQ/OQ/PQ)

Supplier Quality Engineering (i.e. Supplier Audits, Inspection Techniques)

Preferred

ASQ Certified Quality Engineer or Certified Quality Auditor

This position requires direct contact with an implantable device. ☐ Yes ☒ No

Company

Teleflex

Glassdoor

3.9

Teleflex is a diversified global company, distinguished by a significant presence in healthcare, with niche businesses.

Founded in 1943

Royersford, Pennsylvania, USA

10,001+ employees

http://www.teleflex.com

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)