Quality Assurance Manager
Company: Advanced Orthopaedic Solutions Inc.
Position: Quality Assurance Manager
Location: Torrance, CA
Posted: July 15, 2020
Are you an experienced Quality Assurance Manager? Do you want to work for a worldwide industry leader in the orthopaedic trauma market? If so, we want to talk to you!
As a Quality Assurance Manager, key responsibilities include:
• Leading and coordinating quality-related internal and external audit activities.
• Using statistical control and analysis of performance data for overall improvement to the quality management system.
• Creating and maintaining records for sterilization and microbiology related controls for medical devices.
• Developing and maintaining inspection criteria.
• Establishing inspection methods, work instructions and any necessary tooling for efficient and accurate inspection.
• Creating, organizing, and maintaining QA/QC documentation, such as a calibration log, product nonconformities, CAPAs and complaint investigations.
• Conducting mechanical, dimensional, and visual inspections and analyses of First Article and finished parts and components using typical inspection hand measuring devices, coordinate measuring machines (CMM), optical comparators, etc.
• Performing final review of work orders to assure production records are complete and correct.
• Developing and maintaining procedures for the quality management system.
• Ensuring company-wide Quality Assurance in accordance with ISO 13485 Quality Management Systems and 21 CFR 820.
• Managing verification activities through Quality Control and supervising the Quality Control staff.
• Representing Quality Assurance during design control meetings, change control meetings.
• Conducting Annual Quality Management Review meetings.
• Coordinating and hosting the Material Review Board meetings. Preparing documentation and evidence of any incoming product issues (product nonconformities) and communicating with the supplier. Issuing supplier correction action requests (SCAR), if necessary.
• Managing the AOS supplier qualification process.
• Monitoring and evaluating supplier performance and conducting supplier audits on a set schedule for critical suppliers.
• Reading and interpreting manufacturing drawings, manufacturing specifications, and quality control documents.
• Enforcing good manufacturing practices (GMP) and good documentation practices (GDP).
• Other duties as required.
• B.S. in Science-related field or engineering.
• At least 10 years Quality Assurance experience.
• Minimally, 3-5 years of experience in an FDA-regulated medical device manufacturing company. Must have experience inspecting complex machined parts.
• Thorough knowledge of ASME Y14.5 Geometric Dimensioning & Tolerancing.
• Thorough understanding of U.S. FDA QSRs and ISO 13485.
• Knowledge of and ability to use a wide range of precision measuring equipment, including CMM and Comparator.
• Strong command of verbal and written skills in the English language. Should be able to interact well in both individual and team settings.