Manage team to secure compliance to ISO 13485 and FDA QSRs. Safeguarding the health of the Corrective Action Preventative Action System for a medical device (sterile) manufacturer will be major focus for the role.
Manage / supervisor team of technicians and engineers.
Use measured values to monitor KPIs to improve the current Quality Management System.
Supervise and manage the Corrective Action Preventative Action program including all complaints, SCARs, NCMRs, audit findings, etc.
Develop/ implement processes and procedures for cross-functional workflows to secure compliance to all regulatory requirements.
Lead and oversee internal audit team.
Administer and manage the supplier quality program.
Perform risk management activities at all phases of device life cycle.
Lend support and assist management representative with successful external audits.
Ensure compliance with all regulatory requirements.
Bachelor of Science in a field of Engineering with at least minimum 5 years of experience in a supervisory role that involves decision-making duties.
Knowledge of quality control procedures and regulatory requirements (ISO 13485, FDA QSRs, Mdsap, Aami Sterilization standards, etc.).
Analytical decision-making and problem-solving skills needed
Coach / mentor engineering team
Project management, root cause investigation, and implementation of effective corrective actions skills
Experience with risk management activities to support all stages of device life cycle.
Strong verbal and written skills.
Professional certifications preferred related to the field of work [website] ASQ CQM, Lean, Six Sigma, etc.)
Experience with Microsoft Suite and statistical data analysis software.
401k with employee matching available
Vacation, insurance, and other benefits
Equal Opportunity Employer
Job Type: Full-time
Salary: $0.00 /hour
Risk Management: 5 years (Required)
supervisory: 5 years (Required)
Lean Manufacturing: 3 years (Required)
Supplier Quality: 5 years (Required)
Regulatory Compliance: 5 years (Required)
Auditing: 5 years (Required)
quality assurance: 8 years (Required)
Medical Device: 4 years (Required)
Manufacturing: 5 years (Required)
Paid time off
This Company Describes Its Culture as:
Detail-oriented -- quality and Innovative -- innovative and Stable -- traditional, stable, strong processes