Quality Assurance Systems Manager

Lead quality systems, CAPA, and regulatory compliance at Baylis Medical Technologies in a hybrid management role with flexible hours. Guide measurable improvement across medical device operations.As Manager, Quality Assurance and Excellence, you will supervise professional staff and direct quality-system effectiveness, compliance, analysis, and improvement. The scope includes Document Control, Training, CAPA, Complaints, Internal Audits, Recalls, Field Actions, and standards compliance. You will partner with Operations, Supply Chain, Manufacturing, Regulatory, R&D, Sales, Engineering, and Production to implement sustainable improvements.Key Responsibilities:
Lead quality-system execution, maintenance, and continuous improvementEstablish and sustain risk-based CAPA processesOversee document control, training, complaints, audits, and recallsAnalyze quality metrics, trends, risks, and recurring issuesSupervise, coach, and develop Quality Assurance staffRequirements:
Bachelor’s degree in Engineering, Science, or related technical disciplineEight years’ progressive Quality Assurance, Systems, or Excellence experienceFive years’ medical device or regulated-industry experienceFive years’ manufacturing experience and two years’ leadership experienceKnowledge of FDA, ISO 13485, ISO 14971, and related regulationsBring quality-system leadership, CAPA expertise, and regulatory judgment to strengthen Baylis Medical Technologies’ medical device operations.
#J-18808-Ljbffr