Quality Manager - Medical Device
Location:
N. San Diego / S. Orange County, CA
Position Description:
The Quality Manager has primary responsibility for the Quality Management System and to assure compliance to the applicable standards (ISO 13485:2003 and 21 CFR PART 820 and other regulatory requirements.
The individual will act as a management representative for Quality Assurance and ensures that company policies and guidelines are accurately interpreted and implemented.
The manager will have responsibility for managing the QA and Inspection teams ensuring development and adherence to documented standards.
The Quality Manager will promote continuous improvement through management of MRB, CAPA, leading root cause analysis and deploying manufacturing process controls, process validation and change control.
The individual is responsible for the safety, environmental results, quality, efficiencies and effectiveness of the assigned departments.
- Responsible for the maintenance and improvement of Quality Management System (QMS) to ensure the compliance with the applicable quality and regulatory standards.
- Initiate and/or revise Quality Assurance manual, procedures, and SOP to ensure the compliance with the applicable standards: ISO13485 : 2003 and 21 CFR PART 820
- Perform internal and supplier audits in accordance with published schedules and procedures or specifications
- Coordinates management review and promotes improvements to the QMS
- Is the point of contact and individual who accompanies customers during an audit and provides any requested information and documentation for on-site review
- Identifies non-compliance to QMS and corrects or elevates to senior management as appropriate
- Performs QMS awareness training
- Performs detailed trending analysis of related quality data identifying top issues in pareto format, and facilitates problem solving and/or process improvement activities. Develops action plans to reach site objectives
- Coordinates problem solving activities to identify and eliminate root causes of non-conformances (both production and business process) using recognized root cause analysis methods (5 Why, Ishikawa Diagrams, 8D, DoE etc.
- Responsible for QA Inspection activities including:
- Personnel management / performance management
- Maintaining staffing and efficient work flow to meet through put requirements
- Ensuring adequate training and skill level within inspection team to meet quality standards
- Deployment of 5S standards to create world class work environment
- Develops, deploys and monitors process controls plans (In process inspection programs and SPC)
- Technical Skills - Medical Device industry technical knowledge including but not limited, to specification interpretation, product application, product quality, quality systems, ISO 13485 and 21 CFR PART 820, customer relationship management, project management, Six-Sigma, and people development and leadership. Able to clearly share expertise and transfer technical knowledge to others
- Planning/Organizing - Prioritizes and plans work activities of self and others; Uses time efficiently; Plans for resources in a creative way only adding cost as absolutely necessary; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
- SUPERVISORY RESPONSIBILITIES: Directly and/or indirectly supervises Quality Assurance Supervisors, and other employees assigned to the QA departments. Responsible for the overall direction, coordination, and evaluation of the QA departments. Carries out supervisory responsibilities in accordance with the HSE responsibility, organization's policies and applicable laws; Responsibilities include but are not limited to interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Requirements:
Bachelor's Degree in Engineering in related discipline and minimum 5 years directly related experience required and/or training, or equivalent combination of education and experience.
5+ Years quality experience in Medical Device manufacturing
Compensation:
$85,000 - $95,000 Estimated Annual Salary
Industry:
Medical Device
How to apply:
Email your resume as a Word, RTF, or compatible document attachment to:
Jeff Kroh - jkroh@jkroh.com
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