Supplier Quality Engineer

Location:

Marlborough, MA Job Code: 301403 Posted:
Nov 11, 2025

Description:

Mastech Digital provides digital and mainstream technology staff as well as Digital Transformation Services for all American Corporations. We are currently seeking a Supplier Quality Engineer for our client in the Pharmaceutical domain. We value our professionals, providing comprehensive benefits and the opportunity for growth. This is a Contract position, and the client is looking for someone to start immediately.

Duration: 6+ Months Contract (possible for extension or chances for full-time)

Location:

Marlborough, MA

Salary: $50.00-$55.00/Hourly

Role:
Supplier Quality Engineer

Primary

Skills:

Quality Management (QM)

Role

Description:

The Supplier Quality Engineer must have 2-5 years of experience.

Essential Duties and Responsibilities:

* As a resolve of a PPAP certified part number, work with Incoming Quality to include suppliers in the "Skip Lot Program" (as applicable) or remove suppliers out of it if poor quality is detected.

* Maintain complete supplier quality records as per the applicable procedure (e.g., supplier performance key indicators, supplier's quality certifications, etc.).

* Update suppliers' files when required and check that the information is accurate and complete, assuring that all applicable regulatory standards are met.

* Support audits as a subject matter expert. Travel might be required, domestic and international.

* Update the ERP system with the status of the approved suppliers for the different materials (as applicable).

* Attend functional and departmental meetings and follow up on action items accordingly.

* If needed, coordinate/ execute the change in specifications and/or procedures when required through the corresponding change order.

* Get trained in the respective procedures in the training system, before executing the respective task.

* Generate supplier performance metrics to be used in decision making. Provide the necessary reports to the stakeholders.

* As applicable, participate in periodic supplier review meetings, as well as follow up on the activities agreed upon in these meetings to ensure that they are carried out.

* Coordinate and execute activities related to the implementation of new suppliers as a result of the introduction of new products, transfer of products, alternate suppliers, etc.; ensuring that suppliers comply with the requirements stipulated in the quality system before the closure of the projects.

* Qualification of new suppliers and/or new parts/components of an already approved supplier.

* Perform other duties as required by his/her supervisor/manager.

Qualifications/

Skills:

* 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.

* Risk management.

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

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

* PPAP (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…