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 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.

- Full clean driver’s license (desirable).

Education: Bachelor’s degree

Experience: Minimum 2-5 years of experience

Relocation: This position will not cover relocation expenses

Travel: No

Local Preferred: Yes

Note: Must be able to work on a W2 basis (No C2C)

Recruiter Name: Purvi Sonker

Recruiter Phone: 617-848-2353

Benefits:

We have various coverages and additional benefits to choose from:

- Medical, Dental (Including Ortho) & Vision Insurance (Option to Enroll).

- Paid Leaves (Wherever applicable).

- Life & Disability Coverage (Upon eligibility).

- 401K Option, Education Assistance Program and more.

Mastech Digital is an Equal Opportunity Employer - All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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