We are looking for a quality engineer to monitor and improve the quality of our operational processes and outputs. The quality engineer's responsibilities include designing quality standards, inspecting materials, equipment, processes, and products, developing quality control systems, and determining corrective actions. You will also work with managers and supervisors to implement quality measures.

A successful quality engineer should have excellent troubleshooting skills and be able to ensure that processes and products consistently meet established quality standards.

Quality Engineer Responsibilities:

•    Ensure design transfer activities comply with ISO 13485 and quality system requirements.

•    Developing and implementing quality control systems.  

• Review and approve the translation of design input requirements into design output documents.

•    Monitoring and analyzing quality performance.

•    Inspecting and testing materials, equipment, processes, and products to ensure quality specifications are met.

•    Collaborating with operations managers to develop and implement controls and improvements.

•    Drive transfer readiness: FMEA, control plans, CTQs, first-article/PPAP evidence (as applicable).

•    Investigating and troubleshooting product or production issues.

•    Developing corrective actions, solutions, and improvements.

•    Reviewing specifications, and processes.

•    Managing non-conformances through MRB process.

•    Participate in internal and external audits.

Quality Engineer Requirements:

•    Degree in quality, industrial, or mechanical engineering.

•    Lean six sigma background preferred.

•    Experience in fabrication and assembly processes preferred.

•    Minimum of 3 years of experience in quality engineering, quality assurance, or a similar role.

•    Experience with change control processes in a regulated environment. 

•    Strong communication and interpersonal skills.

•    Strong analytical and problem-solving skills. Critical thinking, problem solving, reasoning, complex information processing 

•    Excellent project management skills.

•    Knowledge of FDA, GMP, ISO 9001 and ISO 13485.

•    Knowledge of PFMEA and PPAP processes.