Qualifications: Bachelor’s degree with a major in Science or Engineering preferred. Experience in the Medical Device industry is preferred. Experience and knowledge of medical device Quality System Regulations.
Essential experience and skills:
· Quality orientation and high attention to detail.
· Ability to thrive in start-up environment.
· Excellent interpersonal and communication skills.
· Problem analysis and problem resolution skills.
· Strong knowledge of quality management systems and manufacturing processes.
· Knowledge of the 510(k) process
· Ability and eagerness to learn.
Essential Duties and Responsibilities:
The Quality Engineer will ensure that processes needed for the quality management system are established, implemented and maintained. Will report to top management on the performance of the quality management system and any need for improvement. Will ensure the promotion of awareness of regulatory requirements throughout the organization. Lead focused Quality projects or events as required, to resolve problems or make improvements to specific processes.
Duties and Responsibilities also include:
· Develop and maintain QSR compliant processes which control the quality of parts and product throughout the procurement and production cycle.
· Review results of tests and inspections in DHR or Receiving Inspection History Record.
· Must know, facilitate and implement a quality policy that maintains compliance with applicable Quality System Regulations.
· Actively lead or assist activities in the following areas: Incoming Inspection, Non-Conforming material, CAPA (Corrective and Preventive Actions), Production support, Document Control, Quality Management Reviews, Quality Audits, DHRs, Product Complaints and other associated tasks.
· Work with suppliers, and Production Support personnel in eliminating problems via root cause analysis techniques, to ensure that product quality is monitored and maintained.
· Ensure that the Quality System is in compliance with all Regulatory and Quality System requirements.
· Stay informed on updates to standards and regulations
· Schedule and perform vendor qualifications and equipment calibrations
· Work closely with Operations to resolve in-house and supplier quality problems using established problem solving methodologies (Root Cause Analysis, Mistake-Proofing, etc).
· Participate in conducting internal/vendor audits.
· Establish and maintain regulatory points of contact.