Quality Systems Analyst

Exciting opportunity as a Quality Systems Analyst with a cutting edge entrepreneurial medical device company.Responsibilities:Quality Management Representative. Development and maintenance of the Quality Management System in alignment with the company's mission and in accordance with FDA Code of Federal Regulations, ISO 13485, Medical Device Directives (MDD) and other applicable regulatory requirements. Planning and facilitating quarterly and annual management reviews of the quality management system. Provides leadership in the improvement of quality system policies and procedures.Investigate system gaps and failures and work with business partners to ensure successful resolution. Oversee customer complaint investigations and lead complaint review team.Acts as Internal Lead Auditor having responsibility for developing audit schedules, audit plans, selecting, evaluating and training internal auditors, documenting non-conformance(s) and reporting non-conformance to management. Plans or conducts training for improvement techniques and facilitates quality system improvement activities. This includes control of quality system implementation, assistance and guidance in solving manufacturing and quality issues, and taking an active role in the development and implementation of improvements.
Provides expertise along with subject matter experts in key areas such as Risk Management, including FMEA, Process Validation, and CAPA
Qualifications: Bachelors Degree in Engineering or life sciences (ex:biology, physiology, chemistry)required.CQE or CQA , Minimum 8+ years experience in Quality Systems as an "engineer/professional" in Medical Device Manufacturing. 10 years preferred. Lead Assessor formal training required. Lead Assessor certification desired. Black Belt or Green Belt a plus. Ability to define problems, collect data, establish facts, and draw valid conclusions.
Medical Device Quality System Knowledge including ISO 13485 & QSR. Demonstrated skills in SPC, DOE, FMEA, Risk Analysis. Working knowledge of Quality Improvement Tools & Techniques .Demonstrated Leadership Skills.Demonstrated Project Management Skills .Strong computer skills, Familiar with Lean Manufacturing Practices.Individual must have a hands-on approach.Please email resumes to [Click here for email].
REQUIREMENTS
Bachelors Degree in Engineering or life sciences (ex:biology, physiology, chemistry)required.CQE or CQA , Minimum 8+ years experience in Quality Systems as an "engineer/professional" in Medical Device Manufacturing. 10 years preferred. Lead Assessor formal training required. Lead Assessor certification desired. Black Belt or Green Belt a plus. Ability to define problems, collect data, establish facts, and draw valid conclusions.
Medical Device Quality System Knowledge including ISO 13485 & QSR. Demonstrated skills in SPC, DOE, FMEA, Risk Analysis. Working knowledge of Quality Improvement Tools & Techniques .Demonstrated Leadership Skills.Demonstrated Project Management Skills .Strong computer skills, Familiar with Lean Manufacturing Practices.Individual must have a hands-on approach.Please email resumes to [Click here for email]