Quality Engineer

Join a Growing Medical Manufacturing Operation

Take ownership of high-visibility quality projects in a well-established manufacturer serving highly regulated industries. Recognized for delivering innovative products that improve lives worldwide, the company offers excellent opportunities for professional growth and career advancement.

Job Description

Support manufacturing operations by ensuring compliance with quality system and regulatory requirements. Partner with internal teams during audits, inspections, investigations, and regulatory inquiries. Monitor production processes and maintain compliance with product specifications and documentation requirements. Lead product and process improvement projects using quality and continuous improvement methodologies. Review and approve engineering changes, including BOMs, procedures, drawings, specifications, FMEAs, and control plans. Conduct risk analysis activities and support risk management initiatives. Develop and execute validation protocols, test methods, and supporting reports. Collaborate with Manufacturing Engineering on process validations, capability studies, and new product introductions. Develop and implement inspection methodologies and quality procedures. Manage non-conforming material investigations and corrective action activities. Lead customer complaint investigations and drive effective root cause analysis. Support CAPA initiatives through data analysis, trend identification, and continuous improvement efforts. Work closely with suppliers and internal stakeholders to resolve quality issues and improve performance. Coordinate quality planning activities for new product launches. Provide guidance and support to quality inspectors, technicians, and fellow quality engineers.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

Bachelor's degree in Engineering or a related technical field preferred. Alternatively, 2-5 years of Quality Engineering experience within a regulated manufacturing environment. Experience within medical device manufacturing or a similarly regulated industry. Strong understanding of Quality Engineering tools and methodologies. Knowledge of FDA, ISO 13485, MDSAP, ISO 14971, and other relevant regulatory standards. Experience with root cause analysis, CAPA, risk management, and validation activities. Strong communication and stakeholder management skills. Proficiency with Microsoft Office and Minitab. Ability to manage multiple priorities while maintaining a high level of accuracy and attention to detail. Proven problem-solving skills with a proactive and solutions-focused approach.

What's on Offer

Opportunity to work in a highly regulated and impactful manufacturing environment. Exposure to quality systems, regulatory compliance, audits, and continuous improvement initiatives. Collaborative culture that encourages cross-functional teamwork and knowledge sharing. Career growth opportunities within Quality, Manufacturing, and Engineering functions. Ability to make a tangible impact on product quality, operational excellence, and customer satisfaction.

Job Summary

Sector: Engineering & Manufacturing

Sub Sector: Quality, Technical

Industry: Industrial / Manufacturing

Where: Sturbridge

Contract Type: Permanent

Consultant Name: Bridget Petti

Job Reference: JN-092026-7114666