200+ applicants

Company

Original Job Post

Cirtec Medical · 2 days ago

Quality Engineer II

Lowell, MA

Full-time

Onsite

Mid Level

2+ years exp

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ManufacturingMedical Device

H1B Sponsorship

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Responsibilities

Provide Quality Project Management support as needed for product transfers from development to validation.

Validation System Owner responsible for the development and management of the validation master plan along with the validation determination.

Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable.

Develop and maintain project Quality Plan for assigned projects.

Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.

Provide Quality Engineering support for manufacturing.

CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures.

Interact with customers and suppliers to resolve CAPA and complaint investigations and in support of manufacturing.

Provide Quality Support for the disposition of material via NCR’s.

Provide Quality Project Management Support as needed for product transfers from validation to production.

Comply with all work rules including those pertaining to safety, health, quality, and Cirtec policies.

Qualification

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Data InterpretationQuality ProgramsContinuous ImprovementProblem-SolvingCommunicationAnalyzing informationProcess improvementProcess managementManufacturing proceduresInnovation supportMicrosoft OfficeVerbal communicationOrganizational skillsManagement skills

Required

Bachelor degree required, preferably in an engineering discipline.

Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.

Preferred

Minimum experience in medical/manufacturing environment: 2-5 years

If you're the right person for this opportunity, you will have previous experience providing administrative support to a busy office and using Microsoft Office.

Must possess excellent verbal communication, organizational and management skills.

Analyze and process Information

Promote Process Improvement

Developing Standards

Managing Processes

Manufacturing Methods and Procedures

Supports Innovation

Benefits

Training and career development

Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

Paid Time Off

401(k) retirement savings with a company match

Company

Cirtec Medical

Cirtec Medical provides design, development, manufacturing and product transfer services for the medical device industry.

Founded in 2009

Enfield, Connecticut, USA

1,001-5,000 employees

http://cirtecmed.com/

H1B Sponsorship

Cirtec Medical 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 (4)

2022 (2)

2021 (2)

2020 (9)