Quality Engineer jobs in United States
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SMC Ltd · 10 hours ago

Quality Engineer

positionDevens, MA
timeContract
remoteOnsite
seniorityEntry, Mid Level
money$52K/yr - $90K/yr
date1+ years exp

SMC Ltd. is a strategic manufacturing partner for healthcare innovators, specializing in contract manufacturing for the healthcare industry. As a Quality Engineer, you will ensure that every product meets the highest standards of quality and compliance while collaborating with cross-functional teams and supporting continuous improvement initiatives.

ManufacturingMedical Device
badNo H1Bnote

Responsibilities

Provide Quality Engineering support for the Program Managers on customer programs as required
Review daily rejects and implement or discuss action plans
Manage and investigate customer complaints
Manage CAPAs
Disposition In-Process rejected product from previous day (MRB), if required
Make appropriate changes in documentation as required
Make appropriate changes to fixtures or inspection methods and tools
Regular attendance and professionalism
Create/Maintain FMEA’s, AQPs, Deviations, Process flows, Validation Plans, IQ/OQ/PQ protocol’s, PPAP’s as appropriate
Manage, analyze, and create reports for Process Capability studies, FAIR’s, GR&Rs, and other Validation Data before sending to customer
Create, modify, and maintain History Cards/ Control Plans /Inspection Work Instructions
Make decisions regarding quality related questions as appropriate
Contact customers via verbal/written communication as appropriate
Participate in internal and supplier audits
Manage print reviews, DCNs and ECOs
Participate in design reviews as required
Visit customers and suppliers as warranted
Participate in plant/department meetings and tours as required
Work with Engineering, MFG and Tooling to develop corrective actions and continuous improvement activities
Report any unsafe conditions to Manager or Safety committee member
Maintain cleanliness of work areas and quality measuring equipment
Observe all health and safety requirements
Other duties as assigned

Qualification

Quality EngineeringSPCISO 13485FDA requirementsInspection equipment2D drawingsProblem solvingWordExcelWritten communicationVerbal communicationPresentation skills

Required

2-4-year college degree or Quality related experience
Minimum of 1-3 years of experience in a Quality function
Must be able to read and understand 2D detailed part/article drawings
Must understand the use all Quality related inspection equipment
Must have excellent problem solving and mistake proofing skills
Must have computer skills and familiarity with Word and Excel programs
Must have knowledge of SPC, ISO 13485, and FDA requirements
Ability to work well with others and independently
Excellent written, verbal, and presentation skills

Company

SMC Ltd

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SMC Ltd. offers global solutions, contract manufacturing and molding services for the medical device, diagnostics, and pharmaceutical industries.
dateFounded in 1988
location
Somerset, Wisconsin, USA
people-size501-1000 employees
web-link
http://www.smcltd.com/

Funding

Current Stage
Late Stage

Leadership Team

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Carlos Castro
Talent Acquisition Partner
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Jeff Burke
Human Resource Partner
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Company data provided by crunchbase