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Mastech Digital

Supplier Quality Engineer

Mastech Digital, Marlborough, Massachusetts, us, 01752

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Sr Technical Recruiter at Mastech Digital Responsibilities

Communication —must be able to effectively communicate in both written and verbal forms, and at all levels in the organization.

Ability to use

problem-solving tools (SPC, TQM, etc.)

to optimize processes.

Ability to analyze a situation or data; evaluate relevant identifiable factors and translate this information into a meaningful proposal or action plan.

High proficiency with Microsoft Office suite

to produce reports, analyze data, etc. effectively.

Ability to handle and manage

multiple complex projects .

Knowledge of

project management techniques .

Working knowledge of

Medical Device Regulations/In Vitro Diagnostic Regulation (as applicable), cGMP, CFR 820, ISO-13485, ISO-14971, ISO-9001 .

Must be able to work independently and with all levels of the organization.

ISO 13485 leader auditor

(Desirable).

Quality System Regulation .

Validations (IQ, OQ, PQ) and root cause analysis (CAPA process).

Measurement system analysis (GR&R, AAA) . (Desirable)

Statistical Process Controls (SPC)

and

statistical sampling know how .

Must be able to follow applicable regulations (e.g.

FDA, Canada, Brazil, Japan , etc.)

Education

Bachelor’s degree from a university in an Engineering field.

Depending upon the expertise required by the business, the baseline engineering type might change. For example, if a molding subject matter expert (SME) is required, a

Plastics Engineering

degree might be pursued. On the other hand, if an SME is required in printed circuit boards or electronic components, an

Electronic/Mechatronic Engineer

degree might be required.

ASQ Supplier Quality Engineer Certificate

a plus.

Experience

Minimum 2 years of professional experience , with a Bachelor´s degree, in positions of a similar nature in the

medical industry

in the

technical field , interacting with the

quality management system .

Seniority level Mid-Senior level

Employment type Contract

Job function Engineering and Other

Industries Manufacturing, Medical Equipment Manufacturing, and Medical Practices

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