Our client is a leading global provider of precision instruments, laboratory equipment, consumables, software and services to the research and cell Biology markets. They remain committed to bringing passion, industry knowledge and dedication to the range of products and services that are customer focused, bringing innovations to life. We are presently supporting their search for a Quality Engineer Manager based in Greater Boston MA.

The Quality Engineer Manager, as part of the Quality Assurance Organization, will ensure products are designed, developed, and made to meet/exceed customer requirements. They will ensure all projects, programs and products as well as Quality- Assurance initiatives meet quality, reliability, and compliance requirements to deliver the highest quality products.

JOB RESPONSIBILITIES

• Proactively implements best-in-class Quality Engineering practices.
• Responsible for Product/process assurance plans, master validation plans, validation protocols, inspection plans. regulatory compliance operating procedures to meet FDA and ISO requirements.
• Coordinates with departments across organization supporting data review, design changes - resulting from Non-Conformances, CAPA activities.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Utilizes risk management, robust design principles = development and identification of essential design outputs/ critical to quality (CTQ) attributes.
• Play a hands-on role in design transfer planning, transitioning projects to manufacturing.
• Hosts / coordinates internal and external audits.
• Leads or participates in product, business process or quality system level improvement initiatives and activities.
• Provides training and coaching as needed on Quality System Regulation, ISO, and quality systems requirements.
• All other duties as necessary.

MINIMUM EDUCATION & WORK EXPERIENCE

• Bachelors’ Degree (or foreign equivalent) in Mechanical, Industrial, Biomedical Engineering, Nanoengineering, or related engineering field
• 4 years of experience as a quality or manufacturing engineer for medical devices – In a manufacturing environment.
• One year of auditor experience preferred.
• Working knowledge of national and international regulations applicable to medical devices including Quality System Regulations - 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, EU MDR / MDD.
• Formal training in quality tools preferred (CQE, CQA, Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.)
• Demonstrated ability to work effectively and collaboratively in a team environment and build strong working relationships i.e., excelling in verbal and written communication skills.
• Strong analytical skills and the ability to solve problems through analytical reasoning.
• Ability to work in a fast-paced environment; ability to work well under pressure and maintain positive, enthusiastic attitude.
• High degree of initiative and self-motivation, strong attention to detail and accuracy
• Excellent organization skills: ability to successfully balance and prioritize multiple ongoing projects/tasks.