Quality Engineer - Medical Device - North Smithfield, RI

This role involves ensuring that high-quality standards are consistently met for specialized coating processes, with a focus on products used in medical and high-tech industries. Responsibilities include developing and implementing quality control procedures, analyzing production data, and collaborating with cross-functional teams to identify areas for process improvement.

Client Details

My client is a specialized provider of advanced surface coating solutions, primarily serving industries that require high standards of quality and performance, such as the medical and technology fields. It focuses on enhancing product durability, functionality, and compliance through precise coating processes tailored to industry needs. With a strong commitment to innovation and quality, the company adheres to rigorous standards to deliver solutions that align with specific regulations and quality expectations, making it a trusted partner for clients seeking reliable, high-performance coatings.

Description

• Collaborate with the VP of Quality to oversee the CAPA and NCMR programs by conducting root cause analyses, recommending and implementing corrective and preventive actions, and providing necessary training.
• Work alongside Engineering to perform process validations (IQ/OQ/PQ), conduct risk analyses (PFMEA), and carry out experimental design (DOE) and test method validations with the engineering team.
• Develop and assess inspection and testing methods, as well as tools, to support Operations.
• Partner with Customer Service to review customer prints and establish measurement methods and quality plans.
• Oversee the calibration program for metrology and process equipment, ensuring compliance with standards.
• Draft and update SOPs, work instructions, and quality management documentation as needed.

Profile

• Bachelor's degree in Manufacturing Engineering and at least five years of experience in Quality Engineering within an ISO 13485-certified organization
• Strong verbal and written communication skills
• Proficiency in quality engineering tools and methodologies, including process validation (IQ/OQ/PQ), risk analysis (PFMEA), experimental design (DOE), and test method validation
• Proven experience supporting manufacturing facilities
• Familiarity with PPAP (Production Part Approval Process)
• Solid understanding of SPC (Statistical Process Control) and other statistical tools
• Familiarity with gaging techniques and methodologies
• Green Belt/Black Belt certification and/or ASQ certification strongly preferred
• Skilled in MS Office, ERP manufacturing software, and other relevant quality management tools
• Ability to read and interpret technical documents, including job travelers, blueprints, sketches, diagrams, quality plans, and procedural materials
• Strong attention to detail with a precise and accuracy-focused mindset
• Proficient in using measurement devices and metrology tools, such as laser micrometers and calipers
• Basic understanding of geometry, fractions, percentages, ratios, and measurement principles

Job Offer

• Health insurance
• Dental insurance
• Vision insurance
• Life insurance
• Health savings account (HSA)
• Flexible spending account (FSA)
• 401(k) with matching
• Paid time off (PTO)
• Employee assistance program (EAP)
• Referral program

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.