Burlington, MA, USA
Quality Engineering Manager
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.
- 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
- 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