Rapidly growing medical devices company is seeking a Quality Assurance Manager to lead all quality functions at the company’s site in North San Diego County. The Quality Assurance Manager will help develop and manage the quality management system, team members.
This company develops and produces Class III electromechanical cardiovascular products.
Requirements for the Quality Assurance Manager:
- Bachelors Degree required in engineering, life sciences, or similar technical discipline
- 6+ years’ experience in quality assurance / regulatory affairs QA / RA
- 5+ years’ progressive experience of quality system management in medical devices manufacturing
- A minimum of 2 years’ experience in a leadership role in quality assurance
- Proven accomplishment with medical device QA including, CAPA, root cause analysis, audits, both internal and external.
- Knowledge of process-based risk management system
- Knowledge of Design Assurance and product-based risk management
- Understanding of document control and learning management systems
- Strong working knowledge of cGMP, MDD, FDA 21 CFR 820, ISO 13485, PMDA-JPAL, Canadian Medical Device Requirements
- Working knowledge of quality systems software: configuration management / Learning Management Systems, LMS
- Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines and policy statements.
- Experience with FDA audits as point of contact
- Strong presentation and interpersonal skills
- Strong communication skills; oral, written and electronic
- The ability to think “outside the box” pivot when necessary and manage multiple competing priorities
- Strong attention to detail and accuracy
Responsibilities for the Quality Assurance Manager:
- Direct and provide leadership to all day-to-day quality assurance functions
- Maintain compliance program, ensuring compliance with regulatory requirements, international standards, company policies and procedures.
- Act as management representative with executive responsibility
- Direct both internal and external (supplier) inspections and audits
- Maintain positive working relationships with regulatory bodies.
- Oversee effective resolution of corrective actions to resolve any deficiencies identified during audits
- Lead supplier quality program and relationships with suppliers
- Manage resolution of internal and external audit
- Responsible for the quality management functions related to management review, design control, risk management, CAPA, complaint handling, non-conformance, quality planning and objectives, document management, change control, records management and other areas of responsibility
- Leads Post-Market Quality Activities, including vigilance reporting/MDRs
- Effectively manages complaint and CAPA systems, ensuring timely results, accurate and consistent identification, and compliant documentation and reporting of MDRs or other actions
- Reviews and approves master match record and executed batch record and quality issue resolution, and batch disposition
- Provides training related to regulatory compliance, QMS, or other related subjects as needed