Job Location
Burlington, MA, USA

Position: Quality Engineering Manager

Thank you for submitting your application and for your interest in working with us. We look forward to reviewing your profile and will get back to you shortly if there is a good fit.

Quality Engineering Manager
Description

This position is a hands-on engineer in the shop, a role that offers a significant challenge for the right candidate.

  • Lead development, implementation, communication, and maintenance of company Quality Management System (QMS)
  • Ensure the QMS conforms to the customer, internal, industry (i.e., AS9100, ISO 9001, ISO 13485), and regulatory/legal requirements by conducting audits and identifying gaps.
  • Create Standard Operating Procedures for critical to quality processes
  • Report QMS metrics (e.g., results of quality audits, corrective actions), including the need for improvement
  • Implement a Continuous Improvement Plan
  • Manage the monitoring, measurement, and review of internal processes, especially those that affect part quality
  • Monitor production processes to ensure manufactured parts are per customer specifications and standards.
  • Keep abreast of industry standards, regulations, and laws applicable to the Quality requirements of the products we manufacture.
  • Lead inspection of manufactured parts, issue non-conformance reports, establish MRB, and facilitate the disposition of MRB hardware and task corrective actions.
  • Oversee inspection (examination) of incoming materials, ensuring that they meet specification and certification requirements
  • Responsible for accuracy and timely inspection/calibration of monitoring and measuring devices
  • Audit sub-tier supply chain and create company Yellow Pages of approved processes.
Requirements
  • A bachelor’s degree in engineering is required, as is five years of experience in Quality Assurance/Quality Control
  • Expert knowledge of IS0 9001:2015 Quality Management System certification and implementation
  • Experience working with either Medical Device Quality (ISO 13485:2016 and 21CFR 820s) or Aviation Quality AS9100
  • Experience with current and emerging GMP, FDA QSR, and MedAccred requirements.
  • Ability to lead/educate a diverse team of technologists
  • Excellent attention to detail
  • Data analysis and statistical aptitude
  • Excellent communication skills and the ability to work well with people at all levels are essential
  • Skilled using MS Office
  • Strong organizational, analytical, problem-solving, and management skills
Preferred Experience
  • Cognizant of Quality trends and international regulatory compliance standards including MDD 93/42/EEC, ISO 13485, and other applicable global regulatory requirements
  • Experience working in metals manufacturing for aerospace, defense, or medical devices companies.
  • Experience working in ITAR/EAR compliant organization
  • Experience with Metal Laser Powder Bed Fusion.
  • Project management experience
  • Quality control certification