Manufacturing Quality Engineer

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Manufacturing Quality Engineer

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    Manufacturing Quality Engineer
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Manufacturing Quality Engineer (Marlborough, MA)

We are looking for a Manufacturing Quality Engineer to contribute to the development of new products and sustaining of legacy products with a focus on Manufacturing Quality and Compliance activities.  
• Support Material nonconformance investigation and disposition activity, participate in weekly MRB meetings, follow-up on supplier issues

• Take ownership with maintenance of calibration system

• Support Manufacturing Engineering in the creation, release and maintenance of DHR, routers, bills of material, and specifications for manufacturing

• Engages in continuous improvement activities by identifying opportunities and recommending improvements to product design and manufacturing processes. Provides ongoing quality engineering support throughout the product lifecycle, including risk management, design and manufacturing changes and CAPA investigations.

• Drives supplier quality improvement by providing engineering analysis related to component specifications and root cause analysis. Partners with key suppliers and manufacturing personnel to reduce defects and improve yield. Participates in supplier selection and qualification processes.

• Conduct periodic trend analysis and provides business impact analysis of product and process trends to monitor and take appropriate corrective/preventive actions to ensure product quality, patient safety and compliance with regulatory reporting requirements. Implements problem solving methodologies to reduce internal and external defects.

• Provide quality engineering insight and guidance on product development, product improvement and process improvement projects. Validates key design inputs including usability, reliability, performance, ability to manufacture, safety and effectiveness.

• Plan, control and assure product and process quality in accordance with quality principles and best practices, including process planning, material control, acceptance sampling, measurement systems and process validation. Identifies and implements product and process controls consistent with the outcome of the risk management process.

• Author validation, verification and inspection assessments to ensure product test and manufacturing data support product release. Select appropriate tests and sampling sizes based on critical and statistical calculations.

• Maintains knowledge of relevant quality and regulatory standards and augments quality system processes to meet changing requirements, including the Medical Device Directive, Medical Device Regulation, US FDA, MDSAP and others as required.

• Conduct computer system validation and stay current with validation regulatory requirements.

• Participates in special projects and perform other duties as required. 
Experience Desired:

• 3-5 years of manufacturing experience with Class II/III electro-mechanical medical device field  
• Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred

 • Extensive working knowledge of 21 CFR 820 and ISO 13485

 • Strong working knowledge of Microsoft Word and Excel  

• Hands-on experience with the following manufacturing processes: Plastic Injection Molding, Metal Fabrication, PC Boards, ESD controls, Cabling, Clean room  

• Experience with lasers and optical technologies desired, but not necessary  

• Prior start-up experience is a plus 

  Education Required:

• Bachelor's Degree in electrical engineering or similar engineering field   Personal Requirements:

• Self-starter, with demonstrated ability to follow-through and strong attention to detail  

• Excellent oral and written communication, and interpersonal skills  

• Must be able to interact with customers, consultants, and suppliers  

• Ability to work in an environment with competing priorities is necessary  

• Must be able to work in a cross-functional team environment  

• Physical ability to lift and carry objects up to 25 lbs. 



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