Senior Quality Engineer
3 weeks ago
This role leads Quality Assurance and Quality Engineering activities, supporting high-volume manufacturing and engineering projects. The focus is on developing quality plans and ensuring compliance with quality goals and regulatory requirements throughout product lifecycles. This Senior QE must have product quality experience and be a "hands on" engineer who can inspect product and processes and understand them. Thery also need very strong Root Cause Analysis skills and good technical writing abilities.
Good communication and presentation skills will be key in order to drive actions at a cross-functional level.
Responsibilities
1. Act as a real-time quality support function, embedding quality processes into manufacturing, performing root cause analysis, and promoting data-driven quality improvements. 2. Oversee the integration of quality assurance, risk mitigation, and regulatory compliance into product design and manufacturing processes. 3. Participate in design control activities, evaluating and implementing necessary updates during design and manufacturing changes. 4.
Monitor scrap costs, spearhead initiatives to improve yield and product quality. 5. Lead risk assessment activities, including hazard analysis and failure modes/effects analysis (DFMEA/PFMEA). 6. Support product and process qualifications and evaluations, covering investigations, SPC, and DOE. 7. Design and implement methods for sampling, inspection, defect recognition, and SPC trending using statistical and engineering expertise. 8.
Manage the resolution of investigations, risk assessments, deviations, non-conformance reports (NCRs), and CAPAs. 9. Serve as a subject matter expert during internal and external audits. 10. Collaborate on Quality System training programs for employees. 11. Provide leadership and mentoring for Quality Management Systems, statistical methods, and process optimization.
Qualifications
Education: Bachelors degree in engineering or a related field.
Experience
5+ years in quality engineering within the medical device or a related manufacturing sector.
Skills
Expertise in statistical techniques such as control charts, sampling plans, and design of experiments.
Experience
with FDA GMP practices, CAPA processes, and ISO 13485, EUMDR, 21CFR 820 compliance. Strong understanding of risk management and validation processes in product lifecycle management. Ability to manage multiple projects in a fast-paced environment with minimal supervision. Competence in cross-functional collaboration and technical guidance. #J-18808-Ljbffr
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