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RA/QA Manager

Company Name: A&M Biomedical Inc.
Location: Laguna Hills, CA
Job Type: Full Time
Contact Name: Melissa Fontes
Phone: 949-916-4778
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: TBD

Job Description

Manages regulatory and quality activities to ensure that the company (medical device contract manufacturer) complies with relevant national and international regulations and standards.

• Maintain and support the quality management system to comply with FDA regulations and ISO standards.
• Establish, write, revise, and implement procedures and policies to comply with regulatory and quality requirements.
• Develop and plan regulatory affairs and/or quality projects and activities including analysis of situations or data. Includes representing the regulatory and quality functions on manufacturing and project teams to provide input on regulatory and quality requirements and provide alternatives when appropriate.
• Provides regulatory and quality control leadership and guidance to customers on a task-level. • Review drawings/documentation for new projects and provide NRE estimates for potential customer bids.
• Review and approve protocols, reports, engineering drawings, procedures, labeling and other process development and manufacturing documentation.
• Review and negotiate Quality Agreements
• Administrate Document Control system and maintain all quality system records.
• Monitor and trend quality data from customer product lines.
• Manage ASL and initiate supplier qualification process.
• Train and supervise Quality Control Inspector.
• Manage regulatory inspections (internal and external audits).
• Manage NCR and Corrective and Preventive Action systems.
• Collection and investigation of customer complaints.
• Ensure training of company personnel to quality management system, GDP and GMP.
• Management Representative.
• Participate in risk management activities.
• Report to management on the quality system.
• Other job duties as assigned.

Job Requirements

• A Bachelor’s degree is required.
• 5-10 years of RA/QA experience is required. 
• Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives.
• Strong leadership skills and ability to influence change.
• Strict attention to detail.
• Excellent problem-solving, organizational, analytical and critical thinking skills.
• Ability to manage competing priorities in a fast paced environment.
• Full knowledge and understanding of global regulations relevant to medical devices, Class I, II and III devices.
• Full knowledge and understanding of global regulatory requirements for new products or product changes.
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast paced environment.
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations