Manufacturing Quality Engineer at Intellectt, Inc Manufacturing Quality Engineer at Intellectt, Inc in Marlborough, Massachusetts Posted in about 14 hours ago.

Type:

full-time

Job Title:

Manufacturing Quality Engineer Location:

Marlborough, MA Employment Type:

W2

Contract Duration:

6+

Months Salary/Rate:

$59-$63 per hour on W2 The anticipated pay range for this position is $59-$63 per hour on W2. The actual rate offered may depend on factors such as relevant experience, qualifications, skills, and business needs, consistent with applicable law.

Benefits:

No employer-provided benefits. Job Summary A medical device company focused on women's health is seeking a Manufacturing Quality Engineer with 5+ years of relevant experience in medical device manufacturing and strong expertise in plastic injection molding, tooling, and supplier quality. The ideal candidate will have hands-on expertise with injection molding of larger plastic components and experience supporting mold development, qualification, process validation, supplier quality, and manufacturing quality activities. This position requires demonstrated expertise in plastic injection molding and tooling. Experience limited to plastic components, catheters, or similar products without substantial injection molding and tooling expertise does not meet the primary requirements of this role. Responsibilities Develop, qualify, and improve plastic injection molding processes and production cells. Lead or support mold design reviews and collaborate directly with suppliers on tooling development. Qualify new molds and injection molding processes for production, including

IQ/OQ/PQ

activities. Troubleshoot injection molding defects and lead root-cause investigations and corrective-action activities. Partner with suppliers to address process capability, quality issues, and continuous improvement opportunities. Support supplier qualification, new product introduction (NPI), and sustaining quality activities. Evaluate supplier processes and quality performance and support appropriate corrective and preventive actions. Collaborate with engineering, manufacturing, quality, and supplier teams to resolve technical and quality issues. Support compliance with applicable FDA requirements, ISO 13485, and company quality procedures. Required Qualifications 5+ years of experience in Supplier Quality, Manufacturing Quality, Process Engineering, or a closely related discipline within the medical device industry. Strong hands-on expertise in plastic injection molding, including experience with larger molded components and molding processes. Demonstrated experience with injection mold qualification and tooling development. Experience conducting or participating in mold design reviews. Strong knowledge of injection molding defect troubleshooting and root-cause analysis. Experience with process validation and qualification activities, including

IQ/OQ/PQ.

Working knowledge of CAPA, SCARs, root-cause analysis, and supplier corrective actions. Experience working directly with injection molding suppliers and cross-functional engineering teams. Bachelor's degree in Engineering or a related technical field, or equivalent relevant education and experience where permitted by applicable law. Work Requirements Ability to work onsite in Marlborough, Massachusetts, as required by the position. Ability to collaborate effectively with suppliers and cross-functional engineering, manufacturing, and quality teams. Ability to perform the essential functions of the position with or without reasonable accommodation, consistent with applicable law. Candidates must be authorized to work in the United States in accordance with applicable law. Equal Opportunity Employer We are an equal opportunity employer and consider qualified applicants without regard to legally protected characteristics under applicable federal, state, or local law. Reasonable accommodations are available for qualified individuals with disabilities and for other legally protected needs, as required by applicable law. Application Interested candidates may submit their resume for consideration. Please highlight relevant experience with plastic injection molding, injection mold qualification, tooling development, supplier quality, and medical device manufacturing.