Overview
Quality Assurance Supervisor Jobs in Torrance, CA at Moog Inc.
**ONLY APPLY IF YOU CAN WORK ON-SITE AT SAN RAFAEL, CA**
SUMMARY
S/he will provide leadership, direction, and maintenance of the Company’s Quality Management System (QMS) for all worldwide Medical Device requirements in quality programs and regulatory affairs. S/he will be responsible for all aspects of established quality systems to ensure quality and company objectives are met. S/he will be the designated company Management Representative.
The candidate is responsible for assure compliance with applicable medical device’s state, federal, and international standards and laws, including FDA QSRs, ISO/EN 13485, ISO 14971, etc.
This is a fast-paced hands-on position with a small team at an early-stage company.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Oversee all Quality and Regulatory activities for the company
Must have strong SOP development skills and a complete understanding of Quality Management System requirements.
Ability to manage the Design Control process as the company prepares for the development and manufacture of multiple Class I and Class II devices.
Acquiring CE Marking self-certification for medical devices Class I, creating technical files, and has previously worked with Notified Bodies to acquire CE and TGA approvals.
Manage the flow of all controlled documents under an established Quality System.
Coordinate the review and revision of procedures, specifications, drawings, SOP’s, Work Instructions, labeling, and forms.
Manage all records, hard copies, and electronic files on the network server.
Maintain all associated QA databases related to document control, employee training, CAPA’s, complaints, and all other infrastructure supporting requirements.
Understanding of all processes under the QMS infrastructure, including the requirements for investigations, identifying root causes, implementing corrective and preventive actions, and monitoring changes for effectiveness.
Familiarity with nonconforming material reports and the necessary corrective and preventive actions required for processing.
Approves or rejects products based on compliance with specifications.
Ability to work directly with Contract Manufacturers and suppliers, including the development of applicable agreements.
Establish and generate management reports regarding quality activities in support of Management Review.
Facilitate all Management Review meetings according to schedule.
Serves as primary host in regulatory inspections.
Responds to and resolves general quality issues.
Other duties may be assigned as necessary.
QUALIFICATIONS
Must have a working understanding and knowledge of both U.S. and international regulations, including FDA Quality System Regulations (21 CFR Part 820), ISO 13485 Medical devices — Quality Management Systems, Medical Device Directive (93/42/EEC), and all relevant domestic and international standards as outlined in the company’s Quality Manual.
Must have previous experience in CE marking self-certification and the European MDR process.
Demonstrated ability to perform detail-oriented work with a high degree of accuracy and recall.
Requires strong written, oral, interpersonal, group, and communication skills.
Effective organization and planning skills.
Must be able to follow established policies and procedures, revise or create new procedures, and comply with regulatory requirements.
Strong knowledge of maintaining a document control department with “hands-on” abilities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above and below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must be familiar with quality routine tasks:
Investigation of non-conformances, identification of root cause, and implementation of solutions to prevent a recurrence.
Participation in R&D, new product development, and validation.
Work with manufacturing to implement Quality Improvements (e.g., complaint investigations, defect analysis, control charts, data analysis).
Lead Quality and CIP teams and CAPA.
EDUCATION and/or EXPERIENCE
Bachelor’s Degree
Requires 5+ years of experience in quality assurance in the medical device industry, with a minimum of 3 years of direct ISO 13485 experience and European MDD/MDR.
Job Type: Full-time
Pay: $63,538.46 – $120,794.83 per year
Benefits:
Health insurance
Schedule:
8 hour shift
Education:
Bachelor’s (Preferred)
Experience:
Quality assurance: 6 years (Required)
ISO 13485: 2 years (Required)
Work Location: In person
Title: Quality Assurance Supervisor
Company: Moog Inc.
Location: Torrance, CA
