Position: Regulatory and Quality Manager / Senior Regulatory and Quality Engineer
Reporting: VP Quality and Regulatory
These are only minimum qualifications for this position at this grade level. Other factors are taken into consideration when deciding what position and grade level to place an employee such as performance level, capable contribution level, and company need.
Bachelor's Degree in engineering, science or technical field or equivalent, Master's Degree preferred.
Seven years of working experience in a highly regulated medical device industry (aerospace might also be considered) in one of the fields; Quality, Reliability, Regulatory, or R&D.
Diverse regulatory submissions experience ( 510K, PMA, EU Class 3).
Diverse Geographical Regulatory requirement handling (e.g., US, EU, APAC, Australia)
Experience with Quality Management Systems, internal/external audits, CAPA, Change Control, Complaint handling, Transfer from R&D to Production, Post Market Surveillance, supplier quality, and design controls is preferred.
Working experience with applicable and regulatory standards (including, but not limited to: ISO13485:2016, MDD, MDR , and QSR).
Ability to work in a team environment and Value other ideas.
Works well in a fast-paced environment.
Organized and able to attain results on several projects simultaneously.
Ability to transfer technical expertise by teaching, developing and mentoring employees and vendors personnel.
Ability to work well with a diverse group of people.
Process & Results oriented.
Strong oral and written communication skills
Nice to Have
Experience participant in audits.
Working knowledge of process improvement skills, including Six Sigma, Lean Sigma, Knowledge Management, Process Design.
Experience in utilization methods such as design of experiments, risk management, validation, verification, systematic problem solving, and statistical analysis.
CQE, CQM, RAC
Knowledge of Geometric Dimensioning and Tolerancing (GD&T).
Experience with root cause investigation methodologies.