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Quality Engineer

Burlington, MA 01805

Posted: 05/27/2022 Employment Type: Direct Hire Category: Engineering Job Number: 61803 Pay Rate: 95,000

Job Description



We are seeking a Quality Engineer for our  med device client!  Are you an experienced Quality Engineer with experience in medical device and capital equipment? Do you thrive in a fast-paced hands-on environment and love all aspects of quality? Do you have experience programming CMMs and electrical and mechanical inspection? Our client is a well-respected, growing biotechnology capital equipment manufacturer. This is an excellent direct hire opportunity!

Quality  Engineer responsibilities:
• Provide primary support to QA/QC, R&D, Manufacturing, and other departments to ensure products are developed, manufactured, delivered, and serviced in compliance with regulations and customer needs

 • Develop Quality Plans for inspection and test of incoming parts, components, assemblies, systems, products; WIP and final materials, in accordance with established quality standards, sampling & inspection plans, and test procedures.

• Develop Quality plans for In-process and Final-Inspection of customized single use system of fluidic handling components for bioprocessing applications

 • Develop methods for Quality process control measurements and inspections

 • Working knowledge of manufacturing processes, including but not limited to the manufacture of complex electro-mechanical equipment, capital equipment for Medical, Industrial and semiconductor industry.

• Professional with knowledge of Quality and Regulatory requirements, practices, and tools

• Knowledge of worldwide GMP requirements (210, 211, ICH), FDA QSR, ISO13485 and ISO14971 Risk Assessment • Experience in hardware, software, product development, verification, and validation

• Experience in continuous improvement, root cause analysis, statistics, (8D, 6M, 3x5 Whys)

• Experience with six sigma, lean

• Excellent communication and technical writing skills

• Ability to work independently, to collaborate effectively in interdisciplinary teams and be individual contributor. • Detail-oriented personality, strong organizational skills

• Demonstrated analytical, project management and problem solving skills

• Able to read, understand and create technical documentation; applies GD&T and can suggest effective approaches

• Ability to thrive in a dynamic small / startup environment

 • Experience with mechanical, electrical inspection

• Experience with CMM programming, fixture design measurement and measurement validation using Gage R&R with ANOVA analysis

• Proficient to expert with electrical and mechanical test equipment, i.e., Height gage, micrometer, dial indicators, gauges, mechanical and electrical measuring equipment, calipers, optical comparator, oscilloscope

• Experience working in a cleanroom environment and related protocols

Education:
  BS/BA in Sciences or Technical Discipline preferred 

• Minimum 3 – 5 years of Quality experience in the life sciences industry preferably with medical devices and or in bioprocess equipment and methods.

  Certifications:
ASQ CQE/CRE/CSQE is desired

Our client offers an excellent compensation package and great growth plan! Apply today! 
 
DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace.   We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be.   Apply today and experience “ The DAVIS Difference”. 
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As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.