Quality Engineer- Medical Equipment- North Smithfield, RI

The Quality Assurance Engineer will manage activities to enhance coated products and processes. Responsibilities include designing Design of Experiments (DOEs), conducting qualifications and validations, and investigating defects to determine corrective actions. This role is crucial for maintaining product integrity and compliance with quality standards, reporting directly to the Vice President of Quality and Compliance.

Client Details

This company is a leading provider of advanced coating solutions, specializing in high-performance applications for various industries, including medical, aerospace, and electronics. With a focus on innovation and quality, it offers a range of services, such as precision coating, surface treatment, and assembly solutions. Utilizing state-of-the-art technology and adhering to strict regulatory standards, the company delivers reliable, high-quality products. It is dedicated to enhancing the performance and durability of components through tailored coating processes and extensive expertise in the field.

Description

In conjunction with the VP of Quality; manage the CAPA/NCMR program by performing root cause analysis, recommending, writing and implementing corrective/preventive action and perform training.

• In conjunction with Engineering develop and conduct process validation (IQ/OQ/PQ), risk analysis (PFMEA), experimental design (DOE) and Test Method Validation along with the PCCI Engineering team.

• Responsible for assessing and developing inspection methods, test methods and tools for Operations.

• In conjunction with Customer Service, review customer prints for determining measurements methods and quality plans.

• Responsible for managing the company calibration program for metrology and process equipment.

• Responsible for writing and revising SOPs, work instructions and Quality Management Systems documentations as necessar

Profile

Experience and Education:

• Bachelor's degree in Manufacturing Engineering or related field, with at least five years in Quality Engineering within ISO 13485-certified environments.

• Strong communication skills, both written and verbal.

• Proficient in quality engineering practices, including process validation (IQ/OQ/PQ), risk analysis (PFMEA), experimental design (DOE), and test method validation.

• Experience in manufacturing support and Production Parts Approval Process (PPAP) required.

• Knowledgeable in Statistical Process Control (SPC) and statistical tools.

• Familiarity with gaging methods; Green Belt/Black Belt or ASQ certifications preferred.

• Skilled in MS Office, ERP systems, and quality management software.

• Ability to interpret job travelers, blueprints, sketches, and quality plans.

• Detail-oriented with expertise in using metrology tools (laser micrometers, calipers, etc.).

• Understanding of basic geometry, fractions, percentages, and measurement concepts.

Job Offer

This role offers a candidate the opportunity to take on a critical position within a quality-focused, ISO 13485-certified organization, where they can apply and expand their expertise in advanced quality engineering practices. The position provides a collaborative environment with direct impact on manufacturing excellence, offering hands-on experience with process validations, risk assessments, and continuous improvement initiatives. Additionally, there is potential for career growth through direct engagement with senior leadership and professional development opportunities, especially valuable for those pursuing certifications like Six Sigma Green or Black Belt or ASQ credentials.

With access to sophisticated quality tools and technologies, competitive compensation, and benefits, this role is ideal for a detail-oriented quality professional looking to make a meaningful impact on product quality and reliability within a dynamic and supportive team setting.

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.