Quality Assurance Manager

JOB RESPONSIBILITIES-

Quality Assurance Manager

QA MGR

Full-Time

Quality Assurance Manager candidates will have the following job responsibilities:

• Quality Management System oversight
• Quality Reporting and Process Improvement
• Supplier Qualification, Internal Audits and CAPA Management
• Establish and maintain a Quality Management System at ROi CPS, LLC that is compliant with 21 CFR Part 820. Review and approve quality system documents, reports and records.
• Ensure Quality Records are established and available, as required by 21 CFR Part 820 and the ROi CPS Quality System. Ensure electronic records and signatures comply with 21 CFR Part 11.
• Ensure adequate Process Controls and Quality Controls are defined and implemented throughout the production process to ensure customer and regulatory requirements are met.
• Collect, analyze and trend quality data. Provide quality performance data for reports and provide evidence-based recommendations for process improvements.
• Supervise Quality Assurance Technicians and Quality Control Technicians.

JOB QUALIFICATIONS-

Quality Assurance Manager

QA MGR

Full-Time

Quality Assurance Manager candidates must meet the following minimum job qualifications:

Education

• BA/BS in sciences, engineering preferred

Experience

• Minimum 5 years of proven experience in the medical device industry
• Minimum 2 years of experience in a supervisory or management role